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

NCT ID: NCT04295603

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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)

Conditions

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Chronic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Toucher Massage intervention

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

Group Type EXPERIMENTAL

Toucher Massage (TM) on the feet

Intervention Type 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.

Homedics Machine intervention

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.

Group Type EXPERIMENTAL

Homedics HM MP RELEX 90 device

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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School of Health Sciences Geneva

OTHER

Sponsor Role lead

Responsible Party

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Gora Da Rocha

Professor assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jules Desmeules, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Christine Cedraschi, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Catherine Bollondy Pauly, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Haute Ecole de Santé

Geneva, , Switzerland

Site Status

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 33548750 (View on PubMed)

Other Identifiers

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2019-00848

Identifier Type: -

Identifier Source: org_study_id

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