Clinical trial NCT05951257: Medical Hypnosis and Music for Palliative Care
Official title: Feasibility and Efficacy of Hypnosis and Music on Pain, Anxiety and Well-being in End-of-life Palliative Care at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Pain Management
Anxiety
Well-being
Keywords: Hypnosis
Music
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2023-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: 2 intervention sessions ; Control group (waiting list): 2 control sessions followed by 2 intervention sessions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to evaluate the efficacy of a personalized multimodal intervention program (MuzHyp) including hypnosis, music or their combination to improve palliative care at home.

The main objective is to evaluate if the intervention program will significantly reduce participants' composite score of pain, anxiety, and unwellness as evaluated by the Edmonton symptom assessment scale (ESAS) immediately after the intervention, and whether this improvement will be significantly greater than that of control sessions.

Detailed description: Context :

Quality of life at home in end-of-life palliative care is an ideal that is often difficult to achieve. Side effects of medications and limited access to resources and services can affect the control of pain, anxiety and well-being. Research shows that musical interventions and the use of medical hypnosis can help reduce pain and anxiety, and thus improve patients' psychological well-being in many clinical settings. In view of this, we have developed an intervention program combining medical hypnosis and music (Bissonnette et al., 2022; https://www.frontiersin.org/articles/10.3389/fpain.2022.926584/full).

Objectives and study design :

The main objective of this randomized control trial is to evaluate the efficacy of a personalized multimodal intervention program including hypnosis, music or their combination on composite score of pain, anxiety and unwellness as evaluated with the ESAS.

The secondary objectives are to assess :

* The evolution of distress and of each of the ESAS variables (pain, fatigue, nausea, depression, anxiety, sleepiness, appetite, unwellness, breathlessness) from pre-test to post-test compared with changes in these variables in the control group.
* The preference for the intervention modality (hypnosis, music or their combination).
* The feasibility of the experimentation in end-of-life palliative care at home.
* The experiential dimensions associated with music and hypnosis
* The subjective experience of the intervention.

Description of interventions :

The intervention program consists of a personalized multimodal intervention involving hypnosis and music. It offers each participant the option to receive (a) the hypnosis intervention presented as guided imagery, (b) the music intervention, or (c) a combination of (a) hypnosis (guided imagery) and (b) music. Each intervention is further personalized by integrating individually preferred imagery and/or music.

Recruitment and allocation procedure :

Adults (n = 40) in palliative home care receiving home support services from CIUSSS-NIM or CISSS-CA and meeting the inclusion criteria are eligible to participate in the project. The clinical team identifies participants who meet the selection criteria and asks them if they would like a visit from a member of the research team. During this visit, each participant is informed of the project and asked to sign the consent form. All participants then choose their preferred intervention modality (a. hypnosis, b. music or c. combination of hypnosis and music) before completing baseline measures including a socio-demographic questionnaire, the ESAS and a distress measure. Participants who choose an intervention with music (modalities a and c) are asked to identify pieces that they expect will generate positive emotions. Participants who choose guided imagery (modalities b and c) are asked to describe a pleasant place.

Participants are then stratified by gender and randomly assigned to the "experimental" group and the "control/waiting list" group. The distribution follows the order previously determined by a random table generated using an Excel function.

Two sessions are offered to the participants of the experimental group. During the sessions, a facilitator takes the pre-interventions measurements (see below), asks the participants to listen to the recorded intervention of 15 to 25 minutes by themselves while he/she waits outside the participant's home, and then comes back to fill in the post-intervention measurements (see below). Participants are also asked to report how they feel after each intervention and are given a brief semi-structured interview about their subjective experience.

Procedure in the two intervention sessions:

1. Measures (ESAS; Distress) (3-5 min)
2. Intervention Sessions (15-25 minutes)
3. Measures (ESAS; Distress; Experiential dimensions) (3-5 minutes)
4. Semi-structured interview about the subjective experience (2-5 min)

Participants in the control/waiting list group receive two control sessions following the same procedure as the experimental group but without receiving the intervention. During these control sessions, the same distress and ESAS measures are taken at 20-minute intervals. In the meantime, participants continue to perform their usual daily activities by themselves while the experimenter walk outside the participant's home.

Plan for each control session:

1. Measures (ESAS; Distress) (3-5 min)
2. Usual Daily Activities (20 min)
3. Measures (ESAS; Distress) (3-5 min)

After the two control sessions are completed, participants in the control/waiting list group receive two intervention sessions, following the same procedure as the experimental group. These supplementary sessions are not part of the main analysis design but will be examined as they provide additional pre-post intervention data.

Main objective:

To analyze the changes in the composite score of pain, anxiety, and unwellness between the beginning and the end of the sessions as a function of the group (control/waiting list vs. experimental), a mixed model repeated measures analysis procedures will be performed using SPSS software (GLM model). Data from all participants who completed at least one session will be retained and included in the analyses. Missing scores will be imputed by the model. We have also planned a sensitivity analysis taking into account the baseline level of the dependent variables, if there is a risk of a floor effect.

The data acquired in the additional sessions for the control group will be analysed separately and compared to the pre-post data obtained in sessions 1 and 2 in the same participants and in the experimental group.

The secondary objectives:

To assess the evolution of distress and of each of the ESAS variables of the experimental group from pre- to post-intervention and to evaluate the composite score for the intervention sessions in the control/ waiting list group we will apply a similar GLM model.

To assess the preference of the intervention modality (hypnosis, music, or hypnosis and music), we will count the frequency of selection of each intervention modality for all participants.

To assess the experiential aspects of the intervention, we will calculate the mean for each of the eight experiential dimensions.

To explore the subjective experience of the intervention, two open questions will be asked by the facilitator to inquire about the participant's current feeling and about their impression of change.

Eligibility criteria: Inclusion Criteria:

* End-of-life palliative care at home
* Between 30% and 79% on the Karnofsky Performance Index
* With adequate communication skills to complete the steps of the research
* With satisfactory or corrected hearing, as recommended by the caregiver.
* Severe neurocognitive or psychotic disorders

Exclusion Criteria:

* Severe neurocognitive or psychotic disorders

Primary outcomes:
measure: Changes in Composite pain, anxiety, and unwellness score
timeFrame: The posttest was administered 25 minutes after the pretest.
Secondary outcomes:
measure: Changes in Pain levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Anxiety levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Unwellness levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Fatigue levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Nausea levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Depression levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Sleepiness levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Appetite
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Distress
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Preference of the intervention modality
timeFrame: At baseline
measure: Experiential dimensions
timeFrame: 1 week
measure: Feasibility of the study
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: Subjective experience
timeFrame: 1 week
Locations:
city: Montréal
country: Canada
facility: Ciusss-Nim
state: Quebec
city: Saint-Georges
country: Canada
facility: CISSS-CA
state: Quebec
Study officials:
affiliation: Laval University
name: Josiane Bissonnette, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bissonnette J, Dumont E, Pinard AM, Landry M, Rainville P, Ogez D. Hypnosis and music interventions for anxiety, pain, sleep and well-being in palliative care: systematic review and meta-analysis. BMJ Support Palliat Care. 2024 Jan 8;13(e3):e503-e514. doi: 10.1136/bmjspcare-2022-003551.
citation: Bissonnette J, Pierre S, Duong ATJ, Pinard AM, Rainville P, Ogez D. Development of a Mixed Hypnosis and Music Intervention Program for the Management of Pain, Anxiety, and Wellbeing in End-of-Life Palliative Care. Front Pain Res (Lausanne). 2022 Jul 6;3:926584. doi: 10.3389/fpain.2022.926584. eCollection 2022.