- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02690194
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases.
Relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02115
- Boston Childrens Hospital - Sports Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.
Exclusion Criteria:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo Group
|
The placebo group will wear headphones and listen to nature sounds.
|
Expérimental: Experimental (Buddhify) Group
|
The experimental group will complete a Buddhify relaxation therapy session, before their injection.
This therapy consists of wearing headphones and listening to guided meditation instructions.
|
Aucune intervention: Control Group
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
Délai: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg
|
Pre-therapy/pre-procedure
|
Pre-therapy/Pre-procedure Stress Level Measured by Pulse
Délai: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
|
Pre-therapy/pre-procedure
|
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate
Délai: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
|
Pre-therapy/pre-procedure
|
Pre-therapy/Pre-procedure Anxiety Level
Délai: Pre-therapy/pre-procedure
|
Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory.
The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.
|
Pre-therapy/pre-procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse
Délai: Post-therapy/pre-procedure
|
Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute.
Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
|
Post-therapy/pre-procedure
|
Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate
Délai: Post-therapy/pre-procedure
|
Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
|
Post-therapy/pre-procedure
|
Post-therapy/Pre-procedure Change in Anxiety Level
Délai: Post-therapy/pre-procedure
|
Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory.
Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.
|
Post-therapy/pre-procedure
|
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure
Délai: Post-therapy/Pre-procedure
|
Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg.
Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.
|
Post-therapy/Pre-procedure
|
Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale
Délai: Immediately post-procedure
|
Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10.
A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome).
|
Immediately post-procedure
|
Drink in Last Hour
Délai: Pre-therapy/Pre-procedure
|
Indication of if the patient has had a drink in the last hour
|
Pre-therapy/Pre-procedure
|
Eat in Last Hour
Délai: Pre-therapy/Pre-procedure
|
Indication of if the patient has eaten in the last hour
|
Pre-therapy/Pre-procedure
|
Exercise in Last Hour
Délai: Pre-therapy/Pre-procedure
|
Indication of if the patient has exercised in the last hour
|
Pre-therapy/Pre-procedure
|
Injection Experiences
Délai: Pre-therapy/Pre-procedure
|
Indication of prior injection experiences
|
Pre-therapy/Pre-procedure
|
Number of Injections
Délai: Pre-therapy/Pre-procedure
|
Average number of injections for patients that indicated that they previously have had injections
|
Pre-therapy/Pre-procedure
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gianmichel Corrado, MD, Boston Children's Hospital
Publications et liens utiles
Publications générales
- Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27.
- Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5.
- Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21.
- Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.
- Ko YL, Lin PC. The effect of using a relaxation tape on pulse, respiration, blood pressure and anxiety levels of surgical patients. J Clin Nurs. 2012 Mar;21(5-6):689-97. doi: 10.1111/j.1365-2702.2011.03818.x. Epub 2011 Nov 17.
- Ebrecht M, Hextall J, Kirtley LG, Taylor A, Dyson M, Weinman J. Perceived stress and cortisol levels predict speed of wound healing in healthy male adults. Psychoneuroendocrinology. 2004 Jul;29(6):798-809. doi: 10.1016/S0306-4530(03)00144-6.
- Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available.
- Sugimoto D, Slick NR, Mendel DL, Stein CJ, Pluhar E, Fraser JL, Meehan WP 3rd, Corrado GD. Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial. J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211006031. doi: 10.1177/2515690X211006031.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB-P00016464
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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