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Clinical Trials/NCT04295603
NCT04295603
Completed
Not Applicable

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.

School of Health Sciences Geneva2 sites in 1 country82 target enrollmentOctober 1, 2019
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
School of Health Sciences Geneva
Enrollment
82
Locations
2
Primary Endpoint
Global impression of change
Status
Completed
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
June 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
School of Health Sciences Geneva
Responsible Party
Principal Investigator
Principal Investigator

Gora Da Rocha

Professor assistant

School of Health Sciences Geneva

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

Outcomes

Primary Outcomes

Global impression of change

Time Frame: Baseline, two weeks

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)

Secondary Outcomes

  • Severity of pain(Baseline, two weeks)
  • The patient's perception of their interaction with the caregiver(Baseline, two weeks)
  • Anxiety, depression(Baseline, two weeks)

Study Sites (2)

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