- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Boston Childrens Hospital - Sports Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
위약 비교기: Placebo Group
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The placebo group will wear headphones and listen to nature sounds.
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실험적: Experimental (Buddhify) Group
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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.
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간섭 없음: Control Group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
기간: Pre-therapy/pre-procedure
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Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg
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Pre-therapy/pre-procedure
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Pre-therapy/Pre-procedure Stress Level Measured by Pulse
기간: Pre-therapy/pre-procedure
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Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
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Pre-therapy/pre-procedure
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Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate
기간: Pre-therapy/pre-procedure
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Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
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Pre-therapy/pre-procedure
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Pre-therapy/Pre-procedure Anxiety Level
기간: Pre-therapy/pre-procedure
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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.
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Pre-therapy/pre-procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse
기간: Post-therapy/pre-procedure
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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.
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Post-therapy/pre-procedure
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Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate
기간: Post-therapy/pre-procedure
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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.
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Post-therapy/pre-procedure
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Post-therapy/Pre-procedure Change in Anxiety Level
기간: Post-therapy/pre-procedure
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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.
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Post-therapy/pre-procedure
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Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure
기간: Post-therapy/Pre-procedure
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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.
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Post-therapy/Pre-procedure
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Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale
기간: Immediately post-procedure
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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).
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Immediately post-procedure
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Drink in Last Hour
기간: Pre-therapy/Pre-procedure
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Indication of if the patient has had a drink in the last hour
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Pre-therapy/Pre-procedure
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Eat in Last Hour
기간: Pre-therapy/Pre-procedure
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Indication of if the patient has eaten in the last hour
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Pre-therapy/Pre-procedure
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Exercise in Last Hour
기간: Pre-therapy/Pre-procedure
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Indication of if the patient has exercised in the last hour
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Pre-therapy/Pre-procedure
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Injection Experiences
기간: Pre-therapy/Pre-procedure
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Indication of prior injection experiences
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Pre-therapy/Pre-procedure
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Number of Injections
기간: Pre-therapy/Pre-procedure
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Average number of injections for patients that indicated that they previously have had injections
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Pre-therapy/Pre-procedure
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gianmichel Corrado, MD, Boston Children's Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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