- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07585240
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Effect of Warm Foot Bath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery: A Randomized Controlled Trial
Chest tube removal is a widely used surgical procedure, particularly in the post-cardiac surgery period, to maintain cardiopulmonary stability, provide mediastinal drainage, and prevent potential complications. It provides one-way drainage of air and/or fluid accumulated in the pleural space through closed drainage systems. Chest tube removal is often described by patients as a painful and frightening experience. Without adequate pain control, chest tube removal can cause severe pain and anxiety in patients, limiting their physical activity and negatively impacting coughing and deep breathing. Consequently, this can lead to inadequate expansion of the thoracic cavity and predisposition to respiratory tract infections.
Pain management is considered a fundamental component of nursing care. Effective pain management relies on comprehensive assessment, application of appropriate pharmacological and non-pharmacological interventions, and monitoring of patient response. Pharmacological agents commonly used during chest tube removal include local anesthetics, opioid analgesics, and anti-inflammatory drugs. However, pharmacological methods can have side effects such as vomiting, nausea, respiratory distress, and hypotension, which can reduce patient comfort. Therefore, given the frequent use and potential side effects of pharmacological methods, there is an increasing need for non-pharmacological methods that are safe, easy to apply, and have no side effects in pain and anxiety management. The literature reports that non-pharmacological interventions are effective in reducing pain felt during chest tube removal. Studies in the literature show that relaxation exercises, a non-pharmacological method, are cost-effective, easy to apply, and effective in reducing pain and anxiety levels. These exercises have been shown to provide physiological relaxation by supporting muscle activation and are effective in pain management in patients after surgical procedures. Another non-pharmacological method used to reduce postoperative pain and anxiety is warm foot baths. Warm foot baths are reported to increase peripheral temperature, causing vasodilation, supporting autonomic balance, and providing physiological relaxation. While studies evaluating the effects of warm foot baths on pain and anxiety in various clinical situations exist in the literature, no study examining its effect during chest tube removal has been found. This indicates a significant knowledge gap in the literature regarding the potential effects of warm foot baths during chest tube removal. Accordingly, this research was planned to determine the effects of relaxation exercises applied before chest tube removal and warm foot baths applied simultaneously with relaxation exercises on pain and anxiety levels in patients undergoing cardiac surgery. The research will be conducted using a two-arm, parallel-group, randomized comparative experimental design. Considering the effect sizes reported in the literature for similar interventions and accounting for both literature-based and repeated-measures calculations, a median effect size was assumed. Accordingly, the study targeted a sample size of 30 patients per group (total n=60). The relaxation group (R) and the warm water footbath group (WWF+R) will be assigned using a block-randomized design. The R group will receive guided breathing and progressive muscle relaxation exercises. The WBB+R group will receive guided breathing and progressive muscle relaxation exercises, along with a warm-water foot bath. The interventions will begin with a pre-application to familiarize patients with the procedures. In the second phase, patients will perform the procedures 15 minutes before the scheduled chest tube removal time. Data will be collected at four time points using the Visual Analog Scale and the State Anxiety Scale. Appropriate statistical methods will be used for data analysis. This research has the potential to be the first randomized comparative study examining the simultaneous effects of a warm-water foot bath and relaxation exercises during chest tube removal after cardiac surgery. The findings are expected to contribute a new, low-cost, non-invasive, and evidence-based intervention to post-surgical nursing care protocols. The research outcomes are expected to improve patient comfort and the quality of clinical care.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Özlem abı, Nurse
- 전화번호: +905538840573
- 이메일: ozlemabi89@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18 years and older
- Followed up with at least one chest tube after elective cardiac surgery -Scheduled for chest tube removal
- Conscious, with a Glasgow Coma Scale (GCS) score of 15
- Hemodynamically stable (Mean Arterial Pressure [MAP] ≥ 65 mmHg, and Peripheral Oxygen Saturation [SpO₂] ≥ 92% on room air or with routine oxygen support)
- No visual or auditory impairments
- Able to speAk and understand Turkish
- No clinically diagnosed neurological or psychiatric disease, and not using regular psychotropic medications
Exclusion Criteria:
- Aged under 18 years
- Presence of diabetic peripheral neuropathy, peripheral vascular disease, or conditions disrupting foot/skin integrity (conditions where a warm water foot bath is contraindicated)
- Hemodynamically unstable (Mean Arterial Pressure [MAP] < 65 mmHg)
- Presence of severe cognitive impairment, psychotic disorder, or hallucinations
- Administered any analgesic medication outside the current analgesia protocol within the last 24 hours
- Glasgow Coma Scale (GCS) score below 15
- Inability to speak Turkish or presence of any condition preventing communication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Warm Water Foot Bath and Relaxation (WFB+R) Group
Patients assigned to this arm will immerse their feet in a basin filled with 40°C warm water while simultaneously performing relaxation exercises.
The relaxation exercises consist of 5 minutes of guided breathing and 10 minutes of progressive muscle relaxation.
This combined intervention begins exactly 15 minutes prior to the chest tube removal procedure.
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Administered exactly 15 minutes prior to chest tube removal.
The structured session lasts a total of 15 minutes and consists of two sequential components: 5 minutes of guided breathing (inhaling for 4 seconds, holding for 4 seconds, and exhaling for 6 seconds), immediately followed by 10 minutes of progressive muscle relaxation.
The muscle relaxation involves systematically tensing muscle groups for 5 seconds and relaxing them for 10 seconds, progressing from the toes up to the head.
Administered exactly 15 minutes prior to chest tube removal.
The patient sits on the edge of the bed and immerses their feet up to the ankles in a basin containing 10-15 liters of water heated to exactly 40°C.
This physical intervention is conducted concurrently with guided relaxation exercises to combine peripheral physical relaxation with central psychological relaxation.
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활성 비교기: Relaxation (R) Group)
Patients assigned to this arm will perform only the relaxation exercises, which consist of 5 minutes of guided breathing and 10 minutes of progressive muscle relaxation.
This intervention begins exactly 15 minutes prior to the chest tube removal procedure.
|
Administered exactly 15 minutes prior to chest tube removal.
The structured session lasts a total of 15 minutes and consists of two sequential components: 5 minutes of guided breathing (inhaling for 4 seconds, holding for 4 seconds, and exhaling for 6 seconds), immediately followed by 10 minutes of progressive muscle relaxation.
The muscle relaxation involves systematically tensing muscle groups for 5 seconds and relaxing them for 10 seconds, progressing from the toes up to the head.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity Assessed by Visual Analog Scale (VAS)
기간: Assessed at four time points: pre-intervention, immediately post-intervention (pre-removal), immediately post-chest tube removal, and 15 minutes post-removal.
|
Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS).
The scale consists of a 10-cm line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "unbearable pain".
Participants mark their pain level on the line, and higher scores represent a greater intensity of pain.
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Assessed at four time points: pre-intervention, immediately post-intervention (pre-removal), immediately post-chest tube removal, and 15 minutes post-removal.
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Anxiety Level Assessed by State Anxiety Inventory (STAI-S)
기간: Assessed at two time points: pre-intervention and 15 minutes post-chest tube removal.
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Anxiety will be measured using the 20-item State Anxiety Inventory (STAI-S).
The STAI-S is scored on a 4-point Likert scale (1=not at all, 4=very much so), with total scores ranging from 20 to 80. Higher scores indicate greater anxiety levels.
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Assessed at two time points: pre-intervention and 15 minutes post-chest tube removal.
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Anxiety Level Assessed by Visual Analog Scale (VAS)
기간: Assessed at two time points: immediately post-intervention (pre-chest tube removal) and immediately post-chest tube removal.
|
Anxiety will be evaluated using a 10-cm Visual Analog Scale (VAS) for anxiety.
The scale ranges from 0, indicating "no anxiety," to 10, indicating "highest anxiety".
Participants mark their anxiety level on the line, and higher scores represent a greater level of anxiety.
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Assessed at two time points: immediately post-intervention (pre-chest tube removal) and immediately post-chest tube removal.
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공동 작업자 및 조사자
스폰서
협력자
간행물 및 유용한 링크
일반 간행물
- Uslu Y, Akbayrak H, Kuytak Ortahisar B, Barak TH. The effect of lavender foot baths on postoperative pain and sleep quality in comparison with foot baths with warm water only-A prospective randomized controlled study. Explore (NY). 2024 May-Jun;20(3):385-391. doi: 10.1016/j.explore.2023.10.003. Epub 2023 Oct 5.
- Tsai CS, Tung HH, Fang CJ, Chen CT. Effectiveness of non-pharmacological interventions for pain reduction following chest tube removal: A systematic review and network meta-analysis. Intensive Crit Care Nurs. 2025 Apr;87:103909. doi: 10.1016/j.iccn.2024.103909. Epub 2024 Nov 29.
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
키워드
기타 연구 ID 번호
- E-37077861-900-197647
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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IPD 공유 액세스 기준
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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. .
Relaxation Exercises에 대한 임상 시험
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Istanbul University - Cerrahpasa아직 모집하지 않음허약한 노인 | 노쇠 증후군 | 노인병 | 프리프레일 노인
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