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result(s) for
"Pain, Procedural - therapy"
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Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial
2020
Aromatherapy with essential oils can be used to relieve children. The aim of this study was to evaluate the correlations between psychological and physiologic findings after lavender oil inhalation among children assigned to undergo tooth extraction. A total of 126 children aged between 6 and 12 years were enrolled in the study. The groups were randomly divided into control and lavender groups. The lavender group inhaled 100% lavender oil for 3 min before the interventions, the control group received no prior application. Psychological assessments were made using face image scale (FIS), Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker pain rating scale (WBS). Physiologic changes were assessed using vital signs evaluations. All parameters were noted prior to applications, after inhalation, anesthesia injection, and tooth extraction. The lavender group showed significant lower anxiety and pain scores after tooth extraction (p < 0.05). Significantly lower levels of blood pressures and a significant pulse rate drop were found after inhalation in the lavender group. A statistically significant increase in heart rate was observed after anesthesia injection and tooth extraction in the control group (p < 0.05).Conclusion: Lavender oil can be preferred as a treatment of choice in routine pediatric dentistry.Trial registration number: NCT04115891 (Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children)What is Known:• Dental anxiety is the most common factor that causes children to have difficulty with the dentist and their parents during treatment.• Aromatherapy with essential oils can be used to relieve children.What is New:• Aromatherapy with lavender oil relieves the child by reducing the level of anxiety and facilitates dental treatment.• During surgical procedures such as local anesthesia and tooth extraction, lavender oil inhalation decreases pain levels of children.
Journal Article
The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial
2024
Background: Coronary angiography, an invasive diagnostic procedure, often induces pain and anxiety in patients. Despite the potential for alleviating discomfort, the use of stress balls as a nonpharmacological intervention during angiography remains underexplored. Objective: This study is aimed at investigating the impact of stress ball application on pain and anxiety levels in patients undergoing angiography. Methods: This randomized controlled trial was conducted on adult patients undergoing angiography at a Cardiovascular Surgery Clinic in Eastern Turkey between January 2023 and June 2023. A total of 120 patients were randomly assigned to receive stress ball application in addition to routine care. Data collection utilized the Numerical Rating Scale (NRS), Patient Information Form, and State‐Trait Anxiety Inventory (STAI). Results: Analysis revealed a significantly lower increase in mean NRS posttest scores among patients in the experimental group compared to the control group ( p < 0.05). Additionally, the mean STAI posttest score demonstrated a significant decrease ( p < 0.05) in the experimental group. A positive and significant correlation was observed between the mean NRS and STAI posttest scores among study group patients ( p < 0.05), indicating a reduction in anxiety levels with decreasing pain. Conclusion: The application of stress balls during angiography was associated with decreased anxiety and pain levels in patients. Stress ball intervention may serve as a beneficial adjunct to pharmacological treatments. This study underscores the potential of nonpharmacological interventions in enhancing patient comfort during invasive procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT06131606 ( http://clinicaltrials.gov ).
Journal Article
Hypnosis for unplanned procedural pain in the intensive care unit: the HYPIC randomized clinical trial
2025
Background
Pain and anxiety are frequent among critically ill patients undergoing unplanned invasive procedures, and pharmacological pain relief is not always possible. Although hypnosis is widely used in planned painful procedures, studies are lacking in this specific setting. Thus, we aimed to assess whether hypnosis plus standard care reduced pain and anxiety in critically ill patients undergoing an unplanned invasive procedure in comparison to standard care.
Methods
The HYPIC trial was a randomized, single-blind, multicenter clinical trial of hypnosis during unplanned invasive procedures versus standard care for critically ill patients conducted in two French intensive care units (ICUs) from December 27, 2019, to January 25, 2022. Patients were randomly assigned to receive hypnosis plus standard care by trained healthcare providers or standard care. The hypnotherapists were in the room for both arms to maintain blindness. The primary endpoint was the difference in pain level experienced during the invasive procedure assessed immediately after the end of the procedure between the two groups. The secondary outcomes were anxiety level, lidocaine consumption and stress experienced by the ICU nurses in charge of the patients.
Results
We included 78 patients. The pain level, assessed with a numeric pain scale (range, 0–10), was not significantly different between the two groups (2.2 ± 2.9 vs. 2.2 ± 3, difference 0 pts [95% CI -1.3; 1.3],
p
= 0.89). The level of anxiety was significantly lower in the hypnosis group (2.4 ± 2.8 vs. 4.1 ± 3, difference − 1.7 [-3; -0.4],
p
= 0.01), as was the level of stress experienced by the ICU nurses (0.1 ± 0.4 vs. 0.9 ± 1.5, difference − 0.8 [-1.3;-0.3],
p
= 0.003), and the patients were three times less likely to require increased lidocaine consumption (odds ratio: 0.3 [0.13–0.84],
p
= 0.02) in the hypnosis group.
Conclusion
While hypnosis did not result in a statistically significant reduction in unplanned procedural pain, it seems to reduce anxiety, increase comfort, and reduce the stress level of healthcare providers.
Trial registration:
The study was registered on ClinicalTrials.gov (NCT04129333) on 14 October 2019, before the first patient was enrolled.
Journal Article
Virtually Augmented Self-Hypnosis in Peripheral Vascular Intervention: A Randomized Controlled Trial
by
Gudmundsson, Louis
,
Qanadli, Salah Dine
,
Rotzinger, David Christian
in
Analgesics
,
Anxiety
,
Cardiovascular system
2023
PurposeHypnosis is useful for diminishing distress during medical procedures. This study investigated the efficacy of virtually augmented self-hypnosis as an adjunctive non-pharmacological method for procedural pain and anxiety relief during endovascular interventions (EVI).MethodsWe compared an immersive distraction experience (clinicaltrials.gov identifier NCT04561596) featuring virtual reality (VR) using a head-mounted display versus treatment as usual (TAU). Patients followed the “Aqua” module (Oncomfort™) consisting of a scuba dive and breathing exercises. They experienced a self-induced dissociative state similar to clinical hypnosis without direct intervention of a professional. Enrollment followed a 1:1 randomized open study (VR or TAU). Patients’ feelings were evaluated just before and after the procedure, and 3 months following intervention. Anxiety was evaluated using the State Trait Anxiety Inventory (STAI) and pain (sensory, emotional, and memory) with a visual analogue scale (VAS).ResultsThis study included 100 patients. Mean anxiety (pre-post) was significantly reduced within groups and between groups (difference of 4.2 points, p = 0.016). The percentage of responders to anxiety lowering were 76 and 46% for VR and TAU, respectively (p = 0.004). The two groups did not significantly differ in mean sensory-intensity and affective emotional pain (pre-post) using VAS, in negative memories concerning remembered pain at 3 months (difference > 1 from immediate post-procedural reported pain intensity), mean procedural time, or the need for analgesic or sedative drugs.ConclusionsVR self-hypnosis has the potential to improve the management of patients’ distress during radiological procedures. It is safe and effective for reducing anxiety during EVI.
Journal Article
The effect of combined non-pharmacological interventions on venous blood sampling pain in preterm infants: a clinical trial study
by
Yadollahzadeh, Fatemeh
,
Nikbakht, Hossein-Ali
,
Zabihi, Ali
in
Analgesics
,
Blood Specimen Collection - adverse effects
,
Care and treatment
2025
Background
Using non-pharmacological methods to reduce the pain of hospitalized infants is one of the most important priorities in the health of newborns. Pain relief during painful procedures can help prevent unwanted physical and psychological effects. This study was conducted with the aim of investigating the effect of combined non-pharmacological interventions on venous blood sampling pain in preterm infants.
Methods
In this clinical trial study, 88 preterm infants admitted to the Neonatal Intensive Care Unit of Rouhani Hospital was randomly assigned to four groups of sucrose (S), the combined group of sucrose and non-nutritive sucking (NS), the combined group of swaddle and sucrose (SS) and the combined group of sucrose, non-nutritive sucking and swaddling (NSS). In order to collect information, were used the premature Infant Pain Profile Scale (PIPP) and demographic characteristics questionnaire.
Results
This study showed that during blood sampling, the difference in the mean pain score of two groups of S and NS was equal to 3.54 (95% CI = 1.85, 5.24) and in two groups S and NSS was equal to 4.68 (95% CI = 2.99, 6.38), and these differences were significant (
P
< 0.001). In addition, the mean pain difference in all study groups was significant in two time periods before-during and during-after blood sampling (
P
< 0.001). Also, the mean pain difference in the two time periods before-during and during-after in NS and NSS groups was significant compared to the control group (sucrose) (
P
< 0.001).
Conclusions
Based on the results of this study, the use of combined non-pharmacological interventions of NSS has been more effective in reducing the pain caused by venous blood sampling than other conditions where two or one non-pharmacological intervention were used.
Journal Article
The Effect of Auricular Massage on Naso‐Oral Suctioning Procedural Pain in Premature Neonates: A Randomized Controlled Crossover Study
by
Ali, Reem A.
,
Oweis, Arwa I.
,
Obeidat, Roa′a F.
in
Analysis
,
Care and treatment
,
Cross-Over Studies
2025
In the neonatal intensive care unit (NICU), premature neonates frequently endure painful procedures that can lead to long-lasting sequelae, underscoring the critical need for safe and effective pain management strategies. Auricular massage has demonstrated significant benefits for children, including anxiety and stress relief. Investigating its effectiveness in alleviating pain in neonates could introduce a valuable nonpharmacological approach to pain management, enhancing the overall care and comfort of these vulnerable infants.
This research is aimed at studying the effectiveness of a 3-min session of auricular massage in reducing pain caused by nasal and oral suctioning among premature neonates in the NICU in Jordan.
A randomized controlled trial employing a single-blind crossover design was conducted in a single hospital. Preterm neonates were randomly assigned to one of two conditions. In Condition I, neonates initially received auricular massage treatment after suctioning, followed, after 2 days, by no massage after suctioning. Conversely, in Condition II, neonates had the reversed sequence, starting with no massage and then receiving auricular massage treatment after 2 days. Pain levels in the neonates were assessed using the Premature Infant Pain Profile-Revised (PIPP-R) scale.
Data from 60 preterm neonates were analyzed using the SPSS Version 28. Chi-square and independent
-tests revealed no significant differences between neonates in the study conditions based on gender (
= 0.43), gestational age (
= 0.41), and body weight (
= 0.35). Paired
-test results indicated a significant difference in pain scores when comparing periods of auricular massage to periods without massage. The mean pain score following auricular massage was 3.63 (SD = 2.36), whereas it was 10.23 (SD = 2.40) in the absence of massage.
Auricular massage for a 3-min duration is an effective nursing intervention that warrants consideration as a nonpharmacological method of pain relief for premature neonates during admission to the NICU.
Journal Article
Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol
2022
Endovascular interventions (EVI) are increasingly performed as minimally-invasive alternatives to surgery and have many advantages, including a decreased need for general anesthesia. However, EVI can be stressful for patients and often lead to anxiety and pain related to the procedure. The use of local anesthetics, anxiolytics, and analgesic drugs can help avoid general anesthesia. Nevertheless, these drugs have potential side effects. Alternative nonpharmacological therapies can improve patients’ experience during conscious interventions and reduce the need for additional medications. The added value of virtually augmented self-hypnosis (VA-HYPO) and its potential to reduce pain and anxiety during peripheral and visceral arterial and venous EVI is unknown. This is a prospective two-arm trial designed to randomize 100 patients in two groups according to the use or not of VA-HYPO during peripheral EVI as a complementary nonpharmacological technique to improve patient comfort. The main objective is to compare per-procedural anxiety, and the secondary aim is to compare the rated per-procedural pain in both groups. The potential significance is that VA-HYPO may improve patients’ experience during peripheral and visceral arterial and venous EVI and other minimally invasive interventions performed under local anesthesia. Trial registration : Our study is registered on clinicaltrials.gov, with trial registration number: NCT04561596 .
Journal Article
Effect of magnetic auricular acupuncture on pain during ophthalmic examination of the newborn: a multicenter, triple-blinded, randomized controlled study
by
Wang, Hongyun
,
Wang, Yanchen
,
Wang, Laishuan
in
Acupuncture
,
Acupuncture, Ear - methods
,
Care and treatment
2025
Introduction
Newborn eye examination is a painful procedure. Untreated pain experiences in infants have both short-term and long-term consequences, and pain control is essential. Unfortunately, non-pharmacological pain strategies are usually ineffective for complex and protracted procedures, whereas many pharmacologic agents have adverse effects. Magnetic auricular acupuncture (MAA) is a new method of pain relief that is potentially safe and effective. The objective of this study was to conduct a large definitive triple blinded randomized controlled trial of MAA for reducing pain in neonates undergoing ophthalmic examination. The trial was registered at the Chinese Clinical Trial Registry (ID number ChiCTR1900027474) on November 14, 2019.
Methods
This was a multi-center randomized controlled trial conducted at 16 tertiary hospitals in the People’s Republic of China. Infants were eligible for participation if they were born at 26 to 42 weeks gestational age (GA) and admitted to participating NICUs during the study enrollment period, and scheduled to receive an eye examination for the first time at <44 weeks’ corrected GA. Written informed consent was obtained from parents. Infants who were critically ill, dying or receiving sedatives were excluded. Infants randomized to the intervention (MAA) group received magnetic stickers applied prior to the ophthalmic procedure. Control group infants received placebo stickers with the magnets removed. We compared the primary outcome of Premature Infant Pain Profile (PIPP) score during the procedure between the two groups.
Results
A total of 408 patients were randomized, but 14 patients in each of the placebo and intervention groups did not receive ophthalmic examination; leaving 190 patients in control group and 190 in intervention group. Infant characteristics were similar in the two groups, mean PIPP scores during eye exam were significantly lower in the intervention group compared to the control group (median (IQR): 10.00 (5.00,13.00) v 12.00 (7.00,14.00), p = 0.038).
Conclusions
MAA may offer an alternative or adjunct to current non-pharmacologic and pharmacologic interventions to alleviate neonatal pain. Future studies should assess combinations of pain interventions and long term outcomes.
Journal Article
Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial
by
Buckle, Miranda
,
Adams, Eleri
,
Slater, Rebeccah
in
Administration, Oral
,
Analgesia
,
Analgesics
2018
Infant pain has immediate and long-term effects but is undertreated because of a paucity of evidence-based analgesics. Although morphine is often used to sedate ventilated infants, its analgesic efficacy is unclear. We aimed to establish whether oral morphine could provide effective and safe analgesia in non-ventilated premature infants for acute procedural pain.
In this single-centre masked trial, 31 infants at the John Radcliffe Hospital, Oxford, UK, were randomly allocated using a web-based facility with a minimisation algorithm to either 100 μg/kg oral morphine sulphate or placebo 1 h before a clinically required heel lance and retinopathy of prematurity screening examination, on the same occasion. Eligible infants were born prematurely at less than 32 weeks' gestation or with a birthweight lower than 1501 g and had a gestational age of 34–42 weeks at the time of the study. The co-primary outcome measures were the Premature Infant Pain Profile–Revised (PIPP-R) score after retinopathy of prematurity screening and the magnitude of noxious-evoked brain activity after heel lancing. Secondary outcome measures assessed physiological stability and safety. This trial is registered with the European Clinical Trials Database (number 2014-003237-25).
Between Oct 30, 2016, and Nov 17, 2017, 15 infants were randomly allocated to morphine and 16 to placebo; one infant assigned placebo was withdrawn from the study before monitoring began. The predefined stopping boundary was crossed, and trial recruitment stopped because of profound respiratory adverse effects of morphine without suggestion of analgesic efficacy. None of the co-primary outcome measures differed significantly between groups. PIPP-R score after retinopathy of prematurity screening was mean 11·1 (SD 3·2) with morphine and 10·5 (3·4) with placebo (mean difference 0·5, 95% CI −2·0 to 3·0; p=0·66). Noxious-evoked brain activity after heel lancing was median 0·99 (IQR 0·40–1·56) with morphine and 0·75 (0·33–1·22) with placebo (median difference 0·25, 95% CI −0·16 to 0·80; p=0·25).
Administration of oral morphine (100 μg/kg) to non-ventilated premature infants has the potential for harm without analgesic efficacy. We do not recommend oral morphine for retinopathy of prematurity screening and strongly advise caution if considering its use for other acute painful procedures in non-ventilated premature infants.
Wellcome Trust and National Institute for Health Research.
Journal Article
Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial
2020
Background
Hysterosalpingography (HSG) is an accepted radiologic diagnostic modality for initial infertility workup, and is generally considered uncomfortable and painful. However, the management of pain related to HSG remains inefficient. As an emerging nonpharmacologic and noninvasive pain control strategy, virtual reality (VR) distraction has been successfully used in areas such as burns, blunt force trauma, hospital-based needle procedures, dental/periodontal procedures, and urological endoscopy patients. This study aims to evaluate the analgesic effect of VR during HSG.
Methods/design
A single-center, parallel-group, randomized controlled trial will be carried out in the Radiology Department of Yinchuan Women and Children Healthcare Hospital, Yinchuan. A total of 200 participants who are scheduled for HSG will be enrolled in this study. The participants will be randomized (1:1) into two groups: a VR group and a blank control group. The VR group will receive routine care plus immersive VR intervention and the blank control group will receive routine care. Outcomes will be monitored at baseline, immediately after HSG and 15 min after HSG for each group. The primary outcome is the worst pain score during HSG by a visual analog scale (VAS). The secondary outcomes include: affective pain, cognitive pain, and anxiety during the HSG procedure; worst pain within 15 min after HSG; patient satisfaction and acceptance with pain management; physiological parameters; adverse effects; HSG results; and immersion perception score of the VR system (for the VR condition only).
Discussion
This study will focus on exploring a simply operated, noninvasive and low-cost analgesia during the HSG procedure. The results of this trial will provide data on the feasibility and safety of VR distraction therapy during HSG.
Trial registration
Chinese Clinical Trial Register,
ChiCTR1900021342
. Registered on 16 February 2019.
Journal Article