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:
Measures (ESAS; Distress) (3-5 min)
Intervention Sessions (15-25 minutes)
Measures (ESAS; Distress; Experiential dimensions) (3-5 minutes)
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:
Measures (ESAS; Distress) (3-5 min)
Usual Daily Activities (20 min)
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.