Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea (HYPNODYS)
Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea: a Multicenter Randomized Controlled Trial
Chronic Obstructive pulmonary Disease (COPD) is a common progressive disorder characterized by persistent airflow limitation. It is usually caused by exposure to tobacco smoke, toxic particles, or toxic gases. COPD is characterized by cough, sputum production, and dyspnea, which is the cardinal symptom and is included in the criteria for severity. Dyspnea is a major source of suffering and disability, especially when it persists at rest.
Despite proper medical treatment, many patients continue to suffer from persistent dyspnea that significantly impairs their daily functioning and quality of life. Complementary approaches such as yoga and relaxation techniques are therefore recommended by some experts. Hypnosis is one of these practices. It has been shown to be effective in the management of both acute and chronic pain and it can abolish several types of experimentally induced dyspnea in healthy volunteers. In adults with COPD, a single hypnosis session has been shown to reduce anxiety immediately, though only temporarily. However, according to a recent retrospective study, a median of three hypnosis sessions increases the distance covered in the 6-minute walk test in COPD patients.
The investigators therefore hypothesize that several hypnosis sessions will improve the quality of life of adult outpatients with COPD who suffer from persistent dyspnea. The study plans to recruit 154 patients with severe dyspnea (mMRC(modified Medical Research Council Dyspnea Scale) 3 or 4). They will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The primary outcome of the study will be the evolution of quality of life, assessed 6 weeks after the start of the study as compared to baseline. Secondary outcomes will focus on changes in exercise capacity, dyspnea, anxiety, depression, dyspnea-related catastrophizing, self-efficacy, and pleasure in life.
연구 개요
상세 설명
The study aims at assessing the effect of medical hypnosis on the quality of life of dyspneic COPD outpatients. It plans to recruit 154 COPD outpatients with severe dyspnea (mMRC 3 or 4). They will have to be treated in accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2024 guidelines, exept for pulmonary rehabilitation that is not required. Inclusion and non-inclusion criteria are provided below. Patients will be randomly assigned to either the experimental or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The objectives of the study will be assessed 6 weeks after enrollment. The primary objective of this study will be to evaluate the benefit of hypnosis in improving the quality of life of outpatients with COPD and persistent dyspnea, compared to a control group that will receive support through standardized telephone calls but no hypnosis.
The primary outcome will be the change in the total score of the St George's Respiratory Questionnaire (SGRQ) which assesses respiratory related quality of life, measured 6 weeks after randomization.
The secondary objectives of the study will be to evaluate the benefit of hypnosis in patients with COPD and persistent dyspnea compared to the control group on the following outcomes:
- The components of quality of life in COPD: symptoms, activity, and impact on daily life. Those components are part of the SGRQ.
- The ability to engage in physical activity. It will will be assessed with the 6-min walk test.
- Dyspnea and its affective, sensory, and emotional dimensions. They will be assessed using the multidimensional dypnea profile (MDP) questionnaire. d) Dyspnea in activities of daily living. It will be assessed using the London Chest Activity of Daily Living (LCADL) scale.
e) The level of anxiety. It will be assessed using the Hospital Anxiety and Depression Scale (HADS).
f) The level of depression. It will also be assessed using the Hospital Anxiety and Depression Scale (HADS).
g) The level of catastrophizing about dyspnea. It will be assessed using the breathlessness catastrophizing scale for chronic obstructive pulmonary disease.
h) The level of self-efficacy. It will be assessed using the COPD Self-Efficacy Scale.
i) The level of pleasure (or the level of anhedonia). It will be assessed using the Snaith-Hamilton Pleasure Scale.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Christian STRAUS, MD, PHD
- 전화번호: +331 42 17 85 78
- 이메일: christian.straus@aphp.fr
연구 연락처 백업
- 이름: Marthe MAHI, Master
- 전화번호: +331 42 16 16 99
- 이메일: marthe.mahi@aphp.fr
연구 장소
-
-
France
-
Paris, France, 프랑스, 75013
- APHP, Hôpital Pitié-Salpêtrière
-
연락하다:
- Christian STRAUS, MD, PHD
- 전화번호: +331 42 17 85 78
- 이메일: christian.straus@aphp.fr
-
연락하다:
- Marthe MAHI, Master
- 전화번호: +331 42 16 16 99
- 이메일: marthe.mahi@aphp.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age >18 years
- COPD (any etiology), referred by a pulmonologist and managed according to GOLD 2024 guidelines except for pulmonary rehabilitation that is not required
- Outpatient follow-up
- Residing in Paris or the inner suburbs for centers located within the city limits, or within a 30-minute drive for centers located outside the city limits of Paris.
- Dyspnea rated as mMRC 3 or 4
- Having signed an informed consent form
Exclusion Criteria:
- Vulnerable individuals (under legal guardianship or curatorship) or deprived of liberty
- Pregnant or breastfeeding women
- Absolute or relative contraindication to the 6 minutes walk test, spirometry or body plethysmography
- Current COPD exacerbation or exacerbation resolved less than one week ago
- Psychosis or other psychiatric disorder likely to interfere with study participation
- Profound hearing impairment
- Cognitive impairment
- Use of psychedelic substances (ex: LSD (Lysergic acid diethylamide), psilocybin, etc.)
- Current participation in interventions that may be related to hypnosis: any kind of meditation, relaxation, sophrology, heart coherence training, yoga, Qi Gong, holotropic breathing, EMDR (Eye Movement Desensitization and Reprocessing) or any psychotherapies involving eye movements, as well as shamanic practices and brief psychotherapies or cognitive-behavioral therapies
- Previous management of dyspnea using hypnosis
- Ongoing pulmonary rehabilitation (physiotherapy outside a structured rehabilitation program initiated before study inclusion is not an exclusion criterion)
- Inability to be reached by phone or teleconsultation
- Lack of health insurance (French social security) coverage
- Participation in another clinical trial
- End of life
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Hypnosis
Five medical hypnosis sessions, each scheduled 7 ± 2 days apart
|
Five medical hypnosis sessions, each scheduled 7 ± 2 days apart
|
|
다른: control
Four standardized telephone calls, made at 7 ± 2 day intervals
|
Four standardized telephone calls, made at 7 ± 2 day intervals
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ)
기간: 6 weeks
|
Change in the total score of the St. George's Respiratory Questionnaire (SGRQ), which assesses respiration-related quality of life, at 6 weeks after randomization and baseline.
The SGRQ is a self-administered questionnaire that assesses three domains: symptoms, activity, and impact on daily life.
It permits calculation of a total score from these three domains, reflecting respiration-related quality of life.
Study participants will complete this questionnaire at the first visit, the randomization visit (V1), and the final visit (V6).
The two visits will take place 6 weeks apart (with an extra week's buffer in case of unexpected delays regarding one of the visits or hypnosis sessions).
(Total score ranges from 0 to 100, 0 = no impact of the disease on quality of life, 100 = maximum impact on quality of life.
|
6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in the three component scores of the SGRQ that assess the quality of life in COPD in terms of symptoms, activity and impact on daily life
기간: 6 weeks
|
The SGRQ permits the calculation of 3 scores related to the quality of life in COPD patients : symptoms, activity and impact on daily life (Total score ranges from 0 to 100, 0 = no impact of the disease on quality of life, 100 = maximum impact on quality of life.).
|
6 weeks
|
|
Change in ability to engage in physical activity
기간: 6 weeks
|
Distance covered during the 6-minute walk test
|
6 weeks
|
|
Change in dyspnea and its affective, sensory, and emotional dimensions
기간: 6 weeks
|
Dyspnea will be assessed using the Multidimensional Dyspnea Profile (MDP) questionnaire (Scores range from 0 to 10-50 for each item with higher scores indicating more severe sensory or emotional dyspnea; 0 = no impact of breathlessness.).
|
6 weeks
|
|
Change in dyspnea in activities of daily living
기간: 6 weeks
|
Dyspnea will be assessed using the London Chest Activity of Daily Living (LCADL) scale (Scores range from 0 to 75, 0 = no limitation of daily activities due to breathlessness.
75 = maximum limitation of daily activities due to breathlessness.).
|
6 weeks
|
|
Changes in levels of anxiety and depression
기간: 6 weeks
|
The levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) (Scores range from 0 to 21 for each subscale, with higher scores indicating more severe anxiety or depressive symptoms, 0-7 = Normal, 11-21 = Probable case of anxiety/depression).
|
6 weeks
|
|
Change in level of catastrophizing about dyspnea
기간: 6 weeks
|
The level of catastrophizing about dyspnea will be assessed using the breathlessness catastrophizing scale (Scores range from 0 to 52, A score of 0 indicates no catastrophizing, whereas a score of 52 indicates maximal catastrophizing) for chronic obstructive pulmonary disease
|
6 weeks
|
|
Change in level of self-efficacy in COPD
기간: 6 Weeks
|
The level of self-efficacy will be assessed using the COPD Self-Efficacy Scale (Scores range from 34 to 170, 34= lowest perceived self-efficacy, 170= greatest perceived self-efficacy).
|
6 Weeks
|
|
Change in level of pleasure (or the level of anhedonia)
기간: 6 weeks
|
The level of pleasure will be assessed using the Snaith-Hamilton Pleasure Scale (Scores range from 0 to 14, 0 = no anhedonia, 14= greatest anhedonia or lowest experienced pleasure).
|
6 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Christian STRAUS, MD,PHD, Assistance Publique - Hôpitaux de Paris
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- APHP251231
- N° IDRCB: 2025-A02601-48 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Due to the procedures approved by the French data privacy authority (Commission nationale de l'informatique et des libertés - CNIL), and the content of the informed consent forms signed by participants, full database transmission is not authorized.
However, consultation of deidentified individual participant data may be considered for editorial boards or qualified researchers, upon reasonable request and under strict regulatory safeguards, subject to prior agreement on terms and conditions of access.
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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. .