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

NCT04295603 | Completed DMC

• 1 other identifier: 2019-00848
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Pain

Keywords

Toucher-Massage; Well-being; Gratitude

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of pain

  Baseline, two weeks

• Anxiety, depression

  Baseline, two weeks

• The patient's perception of their interaction with the caregiver

  Baseline, two weeks

Study Arms (2)

Toucher Massage intervention

EXPERIMENTAL

The intervention for the Experimental Group (EG) includes a massage time of about 15 minutes on the foot area .

Other: Toucher Massage (TM) on the feet

Homedics Machine intervention

EXPERIMENTAL

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.

Other: Homedics HM MP RELEX 90 device

Interventions

Toucher Massage (TM) on the feet OTHER

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.

Toucher Massage intervention

Homedics HM MP RELEX 90 device OTHER

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.

Homedics Machine intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• School of Health Sciences Geneva: lead

Study Sites (2)

Haute Ecole de Santé

Geneva, 1206, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1206, Switzerland

Location

Related 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.

  PMID: 33548750 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jules Desmeules, PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Christine Cedraschi, PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Catherine Bollondy Pauly, MSc

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor assistant

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 4, 2020
• Study Start: October 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)