Impacts of Touch-massage on the Experience of Patients With Chronic Pain: a Mixed Study.

Chronic Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295603
• Other study ID #: 2019-00848
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2023
• Source: School of Health Sciences Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Toucher Massage (TM) on the feet
The intervention for the Experimental Group (EG) includes a massage time of about 15 minutes (according to current Geneva Hospital practice) on the foot area. At least four sessions will be delivered and spread over two weeks. The TM will be provided by the care team. The training time for the workers corresponds to 2 times 2 hours. In order to be as close as possible to a standardized session, practitioners will benefit from an intervention guide.
• Homedics HM MP RELEX 90 device
The Control Group (CG) will benefit from an intervention of identical duration. The treatment consists of a foot massage with a Homedics HM MP RELEX 90 device, a heat-free "shiatsu" program, which lasts about 15 minutes. The use of the Homedics device is no more a common treatment than the practice of Touch-Massage. TM involves a therapeutic relationship between caregiver and patient. It is for this reason that we need a comparator that should allow us to keep the aspect of the massage while decreasing the aspect of the therapeutic relationship and therefore offer us an adequate comparator.

Locations

Country	Name	City	State
Switzerland	Haute Ecole de Santé	Geneva
Switzerland	Hôpitaux Universitaires de Genève	Genève

Sponsors (1)

Lead Sponsor	Collaborator
School of Health Sciences Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global impression of change	Global impression of change will be measured by The Patient Global Impression of Change (PGIC).; Minimum value = 1 (no change or condition has got worse) Maximum value = 7 (a great deal better, and a considerable improvement that has made all the difference)	Baseline, two weeks
Secondary	Severity of pain	The Brief Pain Inventory (BPI) assesses the severity of pain and the impact on activities. The scale contains nine items: four of which have a numerical assessment scale for pain severity ranging from 0-10 (0= no pain and 10 representing the strongest possible). The impact of pain is assessed on general activity activities, mood, walking ability, work, relationships, sleep, and taste for life (0= does not interfere, 10= gene completely). The scale provides two main scores: a severity score and a pain repercussions score.	Baseline, two weeks
Secondary	Anxiety, depression	The Hospital Anxiety and Depression Scale (HADS) is composed of seven items measuring anxiety, and seven items concerning depression.; Minimum value= 0 (never) Maximum value = 3 (really very often). A score greater than or equal to 11 indicates that the person is suffering from anxiety or depression.	Baseline, two weeks
Secondary	The patient's perception of their interaction with the caregiver	The Nurse-Patient-Interaction Scale (NPIS) questionnaire will be used to assess the patient's perception of interaction with caregivers across 14 items.; Minimum value = 1 (not at all) Maximum value = 10 (a lot). The higher the score, the better the interaction with caregivers.	Baseline, two weeks