Clinical trial NCT04295603: Impacts of Touch-massage on the Experience of Patients With Chronic Pain: a Mixed Study.
Official title: Impacts of Touch-massage on the Experience of Patients With Chronic Pain and on the Provider-patient Relationship in Inpatient Settings: a Mixed Method Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Toucher-Massage
Well-being
Gratitude
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric study with a design of non-randomized cluster trial. The treatment is assigned to one of two care units and subjects are allocated to the care unit not according to a randomization process but based on administrative basis.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of this study is to evaluate the impacts of Toucher-Massage on the experience of patients with chronic pain. The study takes place in two rehabilitation internal medicine services of the University Hospitals of Geneva at 2 inpatients units with 78 participants (39 per group).

Detailed description: This is a monocentric study with a design of non-randomized cluster trial with an exploratory qualitative part. The treatment is assigned to one of two care units and subjects are allocated to the care unit not according to a randomization process but based on administrative basis.

The main purpose of this study is to evaluate the impacts of Toucher-Massage (TM) on the experience of patients with chronic pain hospitalized in two rehabilitation internal medicine services.

The main objective is to measure the effects of TM on the global impression of change of the perception of pain.

The secondary objectives are:

1. Measure the effects on

   1. the severity and impact of pain
   2. anxiety/depression
   3. caregiver-patient interaction
2. Explore the experiences of patients benefiting from TM
3. Explore perceptions, resistance, barriers and facilitators regarding the proposed interventions with the health care teams of the units.

The population is patients suffering from chronic pain in two units of the internal medicine rehabilitation service at Beau-Séjour. The two units are similar in terms of care intake and populations cared for.

The required sample size is 78 participants (39 per group)

Eligibility criteria: Inclusion Criteria:

* Hospitalized for a minimum of two weeks
* Suffering from chronic pain for more than 3 months
* Having sufficient command of French in reading, writing or speaking

Exclusion Criteria:

* Documented cognitive impairments, and jeopardizing their ability to discern
* Diagnosed with cancer that does interfere with foot massage (extremities metastases)
* Dermatological conditions that interfere with foot massage
* Suffering from major polyneuropathy
* Taking anticoagulants or bleeding disorders
* Being pregnant
* Having a pacemaker

Primary outcomes:
measure: Global impression of change
timeFrame: Baseline, two weeks
Secondary outcomes:
measure: Severity of pain
timeFrame: Baseline, two weeks
measure: Anxiety, depression
timeFrame: Baseline, two weeks
measure: The patient's perception of their interaction with the caregiver
timeFrame: Baseline, two weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Haute Ecole de Santé
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: University Hospital, Geneva
name: Jules Desmeules, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Christine Cedraschi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Catherine Bollondy Pauly, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Da Rocha Rodrigues MG, Bollondi Pauly C, Thentz C, Boegli M, Curtin F, Luthy C, Cedraschi C, Desmeules J. Impacts of Touch massage on the experience of patients with chronic pain: A protocol for a mixed method study. Complement Ther Clin Pract. 2021 May;43:101276. doi: 10.1016/j.ctcp.2020.101276. Epub 2020 Nov 28.