- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Boston Childrens Hospital - Sports Medicine
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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:
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo Group
|
The placebo group will wear headphones and listen to nature sounds.
|
Eksperimentell: 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.
|
Ingen inngripen: Control Group
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Drink in Last Hour
Tidsramme: 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
Tidsramme: Pre-therapy/Pre-procedure
|
Indication of if the patient has eaten in the last hour
|
Pre-therapy/Pre-procedure
|
Exercise in Last Hour
Tidsramme: Pre-therapy/Pre-procedure
|
Indication of if the patient has exercised in the last hour
|
Pre-therapy/Pre-procedure
|
Injection Experiences
Tidsramme: Pre-therapy/Pre-procedure
|
Indication of prior injection experiences
|
Pre-therapy/Pre-procedure
|
Number of Injections
Tidsramme: Pre-therapy/Pre-procedure
|
Average number of injections for patients that indicated that they previously have had injections
|
Pre-therapy/Pre-procedure
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Gianmichel Corrado, MD, Boston Children's Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB-P00016464
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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