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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Toucher Massage (TM) on the feet
Homedics HM MP RELEX 90 device
Sponsored by
School of Health Sciences Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Toucher-Massage, Well-being, Gratitude

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Haute Ecole de Santé
  • Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Toucher Massage intervention

Homedics Machine intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 17, 2020
Last Updated
June 7, 2023
Sponsor
School of Health Sciences Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04295603
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
School of Health Sciences Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Measure the effects on the severity and impact of pain anxiety/depression caregiver-patient interaction Explore the experiences of patients benefiting from TM 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Toucher-Massage, Well-being, Gratitude

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toucher Massage intervention
Arm Type
Experimental
Arm Description
The intervention for the Experimental Group (EG) includes a massage time of about 15 minutes on the foot area .
Arm Title
Homedics Machine intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Toucher Massage (TM) on the feet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Homedics HM MP RELEX 90 device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global impression of change
Description
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)
Time Frame
Baseline, two weeks
Secondary Outcome Measure Information:
Title
Severity of pain
Description
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.
Time Frame
Baseline, two weeks
Title
Anxiety, depression
Description
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.
Time Frame
Baseline, two weeks
Title
The patient's perception of their interaction with the caregiver
Description
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.
Time Frame
Baseline, two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jules Desmeules, PhD
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Cedraschi, PhD
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Bollondy Pauly, MSc
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haute Ecole de Santé
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
1206
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33548750
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.
Results Reference
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Impacts of Touch-massage on the Experience of Patients With Chronic Pain: a Mixed Study.

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