- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07700680
Effect of 4-7-8 Breathing on AV Fistula Needle Pain in Dialysis Patients: A Randomized Trial
The Effect of a 4-7-8 Breathing Exercise Program on the Management of Arteriovenous Fistula Intervention Pain in Hemodialysis Patients: A Randomized Controlled Trial
연구 개요
상세 설명
This study was designed as a randomized controlled trial. The estimated sample size was calculated using the G*Power 3.1.9.7 software. The calculation was based on parameters from a preliminary study on the effects of breathing exercises in hemodialysis patients (Güvener & Koç, 2025). For the independent two-group t-test, an analysis was conducted assuming 95% power (1-β), a significance level of α=0.05, and a large effect size (d=0.80). As a result, it was determined that 35 participants were needed in each group, for a total of 70 participants. Taking potential dropouts into account, the study will begin with a total of 80 participants, and analyses will be conducted using data from at least 70 participants who have completed the follow-up.
Inclusion Criteria: Age between 18 and 85 years.Receiving hemodialysis treatment three times per week.Literate (able to read and write).No hearing impairment.Native Turkish speaker.On hemodialysis for at least 6 months.Baseline pain score >3 on the Visual Analogue Scale (VAS).Willing to listen to music.
Exclusion Criteria: Presence of a psychological disorder.Communication problems.Diagnosis of cancer.Unwillingness to participate in the study.
Intervention Group Protocol:
Participants in the experimental group will be taught a standardized intervention program consisting solely of the 4-7-8 breathing technique, to be performed before and during AVF cannulation. The program will be implemented during every hemodialysis session for one week (three times a week). The technique will be explained in person by a research nurse before the first session, and patients will be provided with a short instructional video demonstrating the technique step by step. The video will be sent to patients' smartphones to encourage them to practice at home.
4-7-8 Breathing Technique Implementation Protocol (During Cannulation):
During AVF cannulation, while the patient is sitting or lying down in a comfortable position, the following protocol will be followed:
- Pre-Procedure Preparation: Immediately before needle insertion, the research nurse will instruct the patient to begin the breathing exercise.
Simultaneous Application: While the cannulation procedure (skin cleansing, needle insertion) is ongoing, the patient will perform the following cycle:
- 4 seconds: Take a slow, deep breath through the nose.
- 7 seconds: Hold the breath.
- 8 seconds: Exhale slowly and completely through the mouth, pursing the lips slightly.
- Number of Repetitions: This cycle will be repeated 5-6 times in succession to cover the duration of the cannulation procedure. The total duration of the exercise will be approximately 2-3 minutes.
Assessment:
Immediately after the cannulation procedure and breathing exercise are completed, the patient will be asked to rate the intensity of their pain on a Visual Analog Scale (VAS) on a scale from 0 (no pain) to 10 (unbearable pain). This assessment will be repeated after each cannulation session throughout the four-week intervention period.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Being 18-85 years of age or older
- Receiving HD treatment 3 days a week
- Being able to read and write
- Having no hearing impairment
- Having Turkish as their native language
- Having received HD treatment for at least 6 months
- Having a VAS pain score >3
- Agreeing to listen to music
Exclusion Criteria:
Having a psychological disorder
- Having communication problems
- Having cancer
- Not wanting to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental
During AVF cannulation, immediately before needle insertion, the research nurse will instruct the patient to begin the breathing exercise. The patient will perform the following cycle while the cannulation procedure (skin preparation, needle insertion) is underway:
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A non-pharmacological behavioral intervention utilizing the 4-7-8 breathing technique.
Prior to the first session, a researcher nurse provides brief face-to-face training and an instructional video sent to participants' smartphones for home practice.
During AVF cannulation in a comfortable position, the cycle begins just before and continues through needle insertion: inhale for 4 seconds, hold for 7, exhale for 8 through pursed lips.
This 5-6-cycle sequence covers the entire ~2-3 minute procedure.
Applied three times weekly for four weeks, with pain assessed post-cannulation via VAS (0-10).
The intervention reduces procedural pain by activating the parasympathetic system, promoting relaxation, decreasing anxiety, and modulating central pain processing.
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간섭 없음: Control
Participants in the control group, on the other hand, will continue with their current routine hemodialysis care and standard cannulation procedures (without any structured breathing exercises).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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동정맥루 천자 시술 중의 시술 관련 통증 강도
기간: 프로시저 (카뉼레이션 중)
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혈액투석을 위한 바늘 삽입 직후 환자가 경험하는 통증 강도입니다.
이 주요 결과는 무작위 배정 후 두 번째 및 세 번째 혈액투석 세션 동안 측정됩니다(무작위 배정 후 첫 번째 세션은 중재 없이 진행된 런인으로 사용됨).
통증은 10cm 시각 아날로그 척도(VAS)를 사용하여 측정됩니다.
점수 범위는 0에서 10까지이며, 여기서 0cm는 '통증 없음'을 나타내고 10cm는 '상상할 수 있는 최악의 통증'을 나타내며, 점수가 높을수록 통증이 더 심함(더 큰 통증 강도)을 의미합니다.
환자는 라인에 자신의 통증 수준을 표시하고, 점수는 센티미터 단위로 기록됩니다.
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프로시저 (카뉼레이션 중)
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공동 작업자 및 조사자
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 04.02.2026/ 2760
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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