Chronic PainNCT04295603
Impacts of Touch-massage on the Experience of Patients With Chronic Pain: a Mixed Study.
A study testing Toucher Massage (TM) on the feet and Homedics HM MP RELEX 90 device in people with Chronic Pain, run by School of Health Sciences Geneva at 2 sites in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Toucher Massage (TM) on the feet and Homedics HM MP RELEX 90 device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Oct 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Haute Ecole de Santé
Geneva, 1206
Hôpitaux Universitaires de Genève
Geneva, 1206
About this 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.
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).
Read the 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)
- Conditions
- Chronic Pain
- Being tested
- Toucher Massage (TM) on the feet, Homedics HM MP RELEX 90 device
- Keywords
- Toucher-Massage, Well-being, Gratitude
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toucher Massage (TM) on the feetOther
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 deviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Toucher Massage intervention | Experimental | The intervention for the Experimental Group (EG) includes a massage time of about 15 minutes on the foot area . Receives: 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. Receives: Other: Homedics HM MP RELEX 90 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, two weeks
Secondary outcomes (3)
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.
Measured: Baseline, two weeks
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.
Measured: Baseline, two weeks
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.
Measured: Baseline, two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Oct 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gora Da Rocha, School of Health Sciences Geneva
- Investigators
- Jules Desmeules, PhD, Principal investigator, University Hospital, GenevaChristine Cedraschi, PhD, Principal investigator, University Hospital, GenevaCatherine Bollondy Pauly, MSc, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295603
- Sponsor's protocol ID
- 2019-00848
- Other IDs
- 2019
- Status last verified
- Jun 2023
- First submitted
- 17 Feb 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33548750
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04295603
- Acronym / sponsor ID
- 2019-00848
- Conditions
- Chronic Pain
- Keywords
- Toucher-Massage, Well-being, Gratitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Toucher Massage intervention | Experimental | Other: Toucher Massage (TM) on the feetThe intervention for the Experimental Group (EG) includes a massage time of about 15 minutes on the foot area . |
| Homedics Machine intervention | Experimental | Other: Homedics HM MP RELEX 90 deviceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toucher Massage (TM) on the feetThe 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. | Other | Toucher Massage intervention |
| Homedics HM MP RELEX 90 deviceThe 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. | Other | Homedics Machine intervention |
Primary outcome
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)
3 secondary outcomes
Severity of pain
Time frame: Baseline, two weeks
Anxiety, depression
Time frame: Baseline, two weeks
The patient's perception of their interaction with the caregiver
Time frame: Baseline, two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 33548750Da 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jules Desmeules, PhD principal investigator
University Hospital, Geneva
Christine Cedraschi, PhD principal investigator
University Hospital, Geneva
Catherine Bollondy Pauly, MSc principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toucher Massage (TM) on the feet and Homedics HM MP RELEX 90 device in people with Chronic Pain, run by School of Health Sciences Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global impression of change (time frame: Baseline, two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.