- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07698652
Diaphragmatic and Box Breathing on Heart Rate Variability and Perceived Stress (HRV DB BB PSS)
Enhancing Physiological and Psychological Resilience: A Comparative Study of Diaphragmatic and Box Breathing in Physical Therapy Students.
The goal of this clinical trial is to learn if diaphragmatic breathing and box breathing work to enhance resilience and manage stress in physical therapy students. It will also learn about their effects on overall physiological and psychological parameters. The main questions it aims to answer are:
Do these breathing techniques improve heart rate variability (HRV)?
How do these interventions affect participants' perceived stress levels, cognitive performance, and academic achievement?
Researchers will compare diaphragmatic breathing and box breathing to a control group to see if these non-invasive methods work to improve physiological adaptation and manage stress.
Participants will:
Be randomly assigned to practice diaphragmatic breathing, practice box breathing, or join a control group Have their heart rate variability (HRV) measured as a primary sign of physiological adaptation Complete assessments to evaluate their perceived stress, cognitive performance, and academic achievement
연구 개요
상태
상세 설명
The Challenge: Stress in Healthcare Education University life is a demanding transitional period, and students training in healthcare fields like physical therapy often face immense academic and clinical pressures. Research shows that up to 50.1% of physiotherapy students experience high levels of stress, which can surge even higher during their hands-on clinical rotations. This stress is more than just an emotional burden; it actively impairs working memory, reduces attention span, and often leads to lower grades and poorer overall academic performance.
The Goal of the Study This study aims to discover if simple, accessible breathing exercises can help undergraduate physical therapy students build resilience and better manage their stress. Specifically, the research will compare the effectiveness of two distinct breathing techniques-diaphragmatic breathing and box breathing-to see how they impact both the mind (psychological stress and cognition) and the body (physiological adaptation).
How the Study Works The study will involve 60 undergraduate physical therapy students from Deraya University who are currently experiencing moderate to high levels of academic stress. These participants will be randomly divided into three equal groups: The Diaphragmatic Breathing Group: Participants will practice a relaxing, slow-paced breathing pattern. They will inhale through the nose for 4 seconds and exhale through the mouth for 6 seconds, focusing on expanding their abdomen. The Box Breathing Group: Participants will practice a structured technique often used in high-stress tactical environments to enhance stress tolerance. It involves a "4-4-4-4" cycle: inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath out for 4 seconds. The Control Group: Participants will simply continue their normal daily routines without any specific breathing interventions so researchers have a baseline for comparison. The two breathing groups will practice their designated techniques for 15 minutes a day, 6 days a week, over a 4-week period. What is Being Measured?To accurately determine if these techniques work, the study will evaluate several key areas:Heart Rate Variability (HRV): Using a highly accurate chest strap sensor (the Polar H10), researchers will measure the subtle variations in time between heartbeats. HRV is a primary indicator of how well the nervous system is regulating stress and keeping the body balanced. Stress and Resilience: Participants will complete standardized questionnaires to evaluate their perceived stress levels and their ability to "bounce back" from daily challenges. Cognitive and Academic Performance: The study will use specialized cognitive tests (like the Stroop Color-Word Test) to measure attention and executive functioning. It will also evaluate the students' confidence in their ability to manage time, prepare for exams, and succeed academically.
Why This Matters Because academic stress is incredibly prevalent among health sciences students, finding practical, non-medication-based ways to support their mental health is critical. By comparing these two breathing methods, this study hopes to identify an effective, non-invasive tool that students can easily use to lower their anxiety, improve their focus, and ultimately thrive in their demanding academic and clinical environments.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alaa N Abdelhameed Abdelmohsen, B.Sc. in Physical Therapy
- 전화번호: +201061382864
- 이메일: alaa.nasser@deraya.edu.eg
연구 연락처 백업
- 이름: Abdelrahman A Mohamed, B.Sc. in Physical Therapy
- 전화번호: +201124079292
- 이메일: abdelrahmanayman199810@gmail.com
연구 장소
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Minya Province
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Minya, Minya Province, 이집트
- Faculty of Physical Therapy, Deraya University
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연락하다:
- Alaa N Abdelhameed Abdelmohsen, BSc in Physical Therapy
- 전화번호: +201061382864
- 이메일: alaa.nasser1713@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Academic Status: Currently enrolled, full-time undergraduate Physical Therapy students
- Age Range: 18-25 years
- Health Status: Generally healthy individuals with no known chronic respiratory or cardiovascular diseases.
- Informed Consent: Ability and willingness to provide written informed consent and commit to the 4-week protocol (6 sessions/week).
- Stress Level: A baseline score on the Perceived Stress Scale (PSS) indicating at least moderate stress.
Exclusion Criteria:
- Pre-existing Breathing Expertise: Individuals with professional training in yoga (Pranayama), formal meditation, or advanced breath work that might bias the baseline results.
- Medical Conditions: Diagnosed respiratory conditions (e.g., Asthma, COPD).
- Cardiovascular issues (e.g., Arrhythmias, Hypertension).
- Clinical psychological disorders (e.g., Generalized Anxiety Disorder or Panic Disorder) that may require medication.
- Pharmacological Factors: Use of medications that influence the Autonomic Nervous System (e.g., Beta-blockers, antidepressants, or heavy use of stimulants/sedatives).
- Substance Use: Smokers/Vapers
- Excessive Caffeine "Participants consuming more than 400 mg of caffeine per day (equivalent to approximately 4 standard cups of brewed coffee) will be excluded.
- Recent Acute Illness: Any respiratory tract infection or fever within two weeks prior to the start of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Diaphragmatic Breathing Group
Participants will sit comfortably with their hands in their abdomen. They will:
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Diaphragmatic Breathing Group: Participants will sit comfortably with their hands in their abdomen. They will:
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실험적: Box Breathing Group
Participants will perform a structured breath cycle:
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Box Breathing Group: Participants will perform a structured breath cycle:
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간섭 없음: Control Group
Participants will continue their normal daily routines and will not receive any breathing intervention during the study period
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Heart Rate Variability
기간: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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HRV will be measured using the Polar H10 sensor and analyzed through Kubios HRV software to evaluate physiological resilience and autonomic nervous system regulation.
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Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Perceived Stress
기간: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Stress will be measured using the Perceived Stress Scale (PSS-10).
The total score ranges from a minimum of 0 to a maximum of 40.
Higher scores indicate higher levels of perceived stress, representing a worse outcome
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Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Resilience
기간: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Resilience will be measured using the Brief Resilience Scale (BRS).
The score ranges from a minimum of 1 to a maximum of 5. Higher scores indicate higher levels of resilience, representing a better outcome
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Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive Performance
기간: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Cognitive performance will be assessed using the Stroop Color-Word Test.
The score represents the number of correct responses.
The minimum possible score is 0, with no strictly defined maximum.
Higher scores indicate better cognitive performance, representing a better outcome
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Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Academic Achievement
기간: Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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Academic achievement will be assessed using the 9-item Academic Self-Efficacy Scale (ASE).
The total score ranges from a minimum of 9 to a maximum of 63.
Higher scores indicate higher levels of academic self-efficacy, representing a better outcome
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Baseline (pre-intervention) and at the end of the 4-week training period (post-intervention).
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Rana H Elbanaa, Assoiate Professor, Cairo University
- 연구 책임자: Fatma Y Abdelsalam, Lecturer, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CU-AN-19052026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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