Self-hypnosis Training in Chronic Pain Management: A Qualitative Exploratory Study of Patients Practicing Self-hypnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time 1 : Numerical Rating Scale (NRS) from 0 to 10
研究概览
简要总结
Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.
The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.
Adverse events: none expected.
详细描述
A self-hypnosis training program has been developed based on the experience of the program developed in medical oncology (phase I). The aim of this project is to analyze the self-hypnosis practice of chronic pain patients, and to evaluate the training program provided in pain management clinics, by means of qualitative research interviews. It is therefore situated at level Ib of the ORBIT model: Program refinement. Through this study, the investigators also wish to evaluate the effects of the intervention on users. In this context, the investigators hypothesize that patients who practice self-hypnosis show an improvement in their quality of life and a reduction in anxiety and pain levels. At this level, there are two objectives :
- To assess the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T3 (3-month follow-up).
- To assess the effects of hypnosis intervention on (i) change in 24h pain between T0 and T4 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.
Methods
Intervention : Self-hypnosis training Based on the exercises from the oncology pilot project, the investigators redefined a program applicable to the pain clinic (phase I ORBIT). To do so, the investigators maintained the stress and pain management exercises and removed the exercises relating to the management of secondary symptoms of cancer treatment. This new self-hypnosis training program is based on four complementary exercises: two on stress management and two on pain perception. Each exercise is organized according to the same hypnotic framework: induction, deepening, hypnotic work, post-hypnotic suggestions and return to the waking state. Each exercise is derived from the oncology study and has been enhanced by protocols drawn from the experience of other hypnotherapists.
The first exercise involves letting go of the emotions and stress associated with the painful condition, using the rucksack technique: a metaphor enabling the patient to empty an imaginary bag that is heavy and preventing him or her from moving forward. The weight of the bag represents the negative emotions, losses and pain that weigh down the patient's daily life. The second exercise focuses on the notion of acceptance, in the same way as cognitive-behavioral acceptance therapies. Suggestions and metaphors used in the work include the ideas of doing nothing, letting oneself be carried away and meditating in a pleasant place. The third exercise uses visualization techniques to modify pain. The modification concerns the form and intensity of the pain. Finally, the fourth exercise is derived from Rossi's protocol, which proposes mobilizing the patient's resources through levitation and catalepsy techniques. This technique focuses on the body and aims to restore confidence in the body in people with pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were to have participated in the past year in the self-hypnosis training program and to agree to take part in these research interviews.
- •be 18 years of age or older;
- •have received one of the above diagnoses, confirmed by medical record review or physician confirmation;
- •report pain that has been present for at least 3 months;
- •have a pain intensity over the last 24 hours (24h pain) of at least 4 on a Numerical Rating Scale (NRS) from 0 to 10 at baseline;
- •be able to read, speak and understand French;
- •have Internet access and be able to participate in a telepractice intervention group and complete online questionnaires.
排除标准
- •have deafness and/or severe cognitive impairment that may impair communication;
- •have current or recent psychiatric instability (e.g., active suicidal ideation, active delusional or psychotic thoughts) that could interfere with participation, as assessed by a clinical psychologist.
结局指标
主要结局
Time 1 : Numerical Rating Scale (NRS) from 0 to 10
时间窗: First day
24 h pain will be measured using the NRS from 0 to 10 (0 = no pain, 10 = the most horrible pain participants can imagine)
Time 1 : Questionnaire Brief Pain Inventory (BPI)
时间窗: First day
The functional impact of pain will be measured using the Brief Pain Inventory (BPI) with 9-item scale assesses.
Time 1 : Hospital anxiety and depression scale (HADS)
时间窗: First day
Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS).
Time 1 : SF-36 (36-Item Short Form Survey)
时间窗: First day
Quality of life will be assessed by the SF-36 (36-Item Short Form Survey), which comprises 36 questions covering eight health domains.
Time 1 : Questionnaire socio-demographic and clinical
时间窗: First day
A socio-demographic and clinical questionnaire will also be requested.
次要结局
- Time 2 : Numerical Rating Scale (NRS) from 0 to 10(1 month)
- Time 2 : Hospital anxiety and depression scale (HADS)(1 month)
- Time 2 : Questionnaire Brief Pain Inventory (BPI)(1 month)
- Time 2 : SF-36 (36-Item Short Form Survey)(1 month)
研究者
David Ogez
Clinical Assistant Professor, Department of Anesthesiology and Pain Medicine, Université de Montréal
Ciusss de L'Est de l'Île de Montréal
