Quality of Life at WorkPauseTMNCT06928987
Evaluation of the Efficiency of Touch Massage on the Quality of Life at Work of Nursing Staff Working in a Cancer Center. (Pause "Toucher Massage (TM)")
A study testing Touch Massage in people with Quality of Life at Work and Paramedical Professionals, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
The goal of this clinical trial is to scientifically confirming the common perception that Touch-Massage (TM) breaks have a beneficial effect on the daily life of paramedics, both psychologically and physically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life at Work, Paramedical Professionals, Touch Massage
- What is being tested?
- Touch Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurses or nursing assistant working in the Institut de Cancérologie de l'Ouest's (ICO) medical oncology, surgical oncology, day clinic or early phase unit.
- Employees who have worked at the ICO for at least 9 months.
Who cannot join
- Employees who have had more than one touch/massage session at the ICO in the last 6 months.
- Pregnant for more than 4 months (declarative)
- Employees who have undergone osteo-articular surgery within the last 3 months.
- Employees with a pre-inclusion MBI score indicating high burnout (emotional exhaustion score >30 and depersonalisation score >12 and personal accomplishment score <33).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of Touch Massage on the Quality of Life at Work of Nursing Staff Working in a Cancer Center
The goal of this clinical trial is to scientifically confirming the common perception that Touch-Massage (TM) breaks have a beneficial effect on the daily life of paramedics, both psychologically and physically.
The main question[s] it aims to answer [is/are]:
Read more
- Evaluating the efficacy of TM on burnout
- Evaluating the efficacy of TM on anxiety
- Evaluating the efficacy of TM on affect
- Evaluating the efficacy of TM on musculoskeletal disorders Researchers will compare 2 groups : Control group of paramedics who do not have the benefit of TM breaks and an experimental group of paramedics taking TM break.
Participants in the experimental group received one 15-minute TM session per week for 6 weeks and burnout, anxiety, affect, and musculoskeletal disorders (MSDs) will be assessed in participants using questionnaires at different times of the study. Participants in the control group complete only the same questionnaires at the same times as the experimental group.
Participants in the 2 arms are reviewed at 3 and 6 months to complete the questionnaires.
- Being tested
- Touch Massage
- Keywords
- burnout, stress, anxiety, affect, musculoskeletal disorders, well-being
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch MassageOther
The practitioner performs the touch-massage for 15 minutes on clothed personnel in a seated position on an ergonomic massage chair. The massage focuses on the back, neck and arm areas. It's a precise, technical sequence of pressure, stretching and sweeping movements that follows the following pattern:
- Basic anti-stress maneuvers to relieve tension,
- Relaxation of the upper torso with weightless movements to loosen shoulders and arms,
- Stretching,
- Redynamization through rapid friction on the back.
Burnout, anxiety, affect, and musculoskeletal disorders (MSDs) will be assessed in participants using the following questionnaires at different times of the study.
| Study group | Role | What they receive |
|---|---|---|
| Touch massage | Experimental | Participants receive 6 Touch Massage sessions, given once a week for 6 weeks by one of the Touch Massage practitioners Receives: Other: Touch Massage |
| Without Touch massage | No intervention | Participants will not receive any Touch Massage sessions for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burn out
Burnout is assessed using the Maslach Burnout Inventory (MBI) questionnaire, which consists of 3 scales (emotional exhaustion, depersonalisation and personal accomplishment).
This score is obtained by adding items 1, 2, 3, 6, 8, 13, 14, 16 and 20, each of which is rated on a 7-point Likert scale (from 0=never to 6=every day).
- Total < 17: low burnout
- Total between 18 and 29: moderate burnout
- Total > 30: high burnout
Measured: At enrolment and at the end of the 6th session of touch massage (1 session per week for 6 weeks)
Secondary outcomes (3)
Anxiety
Anxiety will be assessed using the State Trait Anxiety Inventory (STAI TRAIT) questionnaire. The questionnaire consists of 20 items that participants answer on a 4-point scale. Scores range from 20 to 80, with higher scores indicating greater anxiety.
Measured: At enrolment, at the end of the 6th session of touch massage (1 session per week for 6 weeks) and 6 months after randomisation
Affect
Affect will be assessed using the Positive And Negative Affectivity Scale (PANAS). The questionnaire consists of 10 items assessing positive and negative affectivity. For each item, the participant responds on an ordered scale of 1 to 5, making it possible to calculate a score ranging from 10 to 50 for each dimension.
Measured: At enrolment, at the end of the 6th session of touch massage (1 session per week for 6 weeks), at 3 and 6 months after randomisation
Musculoskeletal disorders
Musculoskeletal disorders will be assessed using the Nordic Musculoskeletal Questionnaire (NMQ). This questionnaire is used to record problems such as pain, discomfort and numbness in different parts of the body over the past 12 months and also over the past 7 days. It can also be used to assess the intensity of the problem at the time the questionnaire is completed.
Measured: At enrolment, at the end of the 6th session of touch massage (1 session per week for 6 weeks), at 3 and 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start16 May 2024
- Primary completion2 May 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life at WorkStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928987
- Sponsor's protocol ID
- ICO-2023-22
- Acronym
- PauseTM
- Status last verified
- Apr 2025
- First submitted
- 5 Nov 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Touch Massage on the Quality of Life at Work of Nursing Staff Working in a Cancer Center
- ClinicalTrials.gov ID
- NCT06928987
- Acronym / sponsor ID
- PauseTM / ICO-2023-22
- Keywords
- burnout, stress, anxiety, affect, musculoskeletal disorders, well-being
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 15 Apr 2025 (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 goal of this clinical trial is to scientifically confirming the common perception that Touch-Massage (TM) breaks have a beneficial effect on the daily life of paramedics, both psychologically and physically.
The main question[s] it aims to answer [is/are]:
- Evaluating the efficacy of TM on burnout
- Evaluating the efficacy of TM on anxiety
- Evaluating the efficacy of TM on affect
- Evaluating the efficacy of TM on musculoskeletal disorders Researchers will compare 2 groups : Control group of paramedics who do not have the benefit of TM breaks and an experimental group of paramedics taking TM break.
Participants in the experimental group received one 15-minute TM session per week for 6 weeks and burnout, anxiety, affect, and musculoskeletal disorders (MSDs) will be assessed in participants using questionnaires at different times of the study. Participants in the control group complete only the same questionnaires at the same times as the experimental group.
Participants in the 2 arms are reviewed at 3 and 6 months to complete the questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touch massage | Experimental | Other: Touch MassageParticipants receive 6 Touch Massage sessions, given once a week for 6 weeks by one of the Touch Massage practitioners |
| Without Touch massage | No intervention | –Participants will not receive any Touch Massage sessions for the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses or nursing assistant working in the Institut de Cancérologie de l'Ouest's (ICO) medical oncology, surgical oncology, day clinic or early phase unit.
- Employees who have worked at the ICO for at least 9 months.
Key exclusion criteria (4 listed)
- Employees who have had more than one touch/massage session at the ICO in the last 6 months.
- Pregnant for more than 4 months (declarative)
- Employees who have undergone osteo-articular surgery within the last 3 months.
- Employees with a pre-inclusion MBI score indicating high burnout (emotional exhaustion score >30 and depersonalisation score >12 and personal accomplishment score <33).
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 |
|---|---|---|
| Touch MassageThe practitioner performs the touch-massage for 15 minutes on clothed personnel in a seated position on an ergonomic massage chair. The massage focuses on the back, neck and arm areas. It's a precise, technical sequence of pressure, stretching and sweeping movements that follows the following pattern: * Basic anti-stress maneuvers to relieve tension, * Relaxation of the upper torso with weightless movements to loosen shoulders and arms, * Stretching, * Redynamization through rapid friction on the back. Burnout, anxiety, affect, and musculoskeletal disorders (MSDs) will be assessed in participants using the following questionnaires at different times of the study. | Other | Touch massage |
Primary outcome
Burn out
Time frame: At enrolment and at the end of the 6th session of touch massage (1 session per week for 6 weeks)
Burnout is assessed using the Maslach Burnout Inventory (MBI) questionnaire, which consists of 3 scales (emotional exhaustion, depersonalisation and personal accomplishment). This score is obtained by adding items 1, 2, 3, 6, 8, 13, 14, 16 and 20, each of which is rated on a 7-point Likert scale (from 0=never to 6=every day). * Total < 17: low burnout * Total between 18 and 29: moderate burnout * Total > 30: high burnout
3 secondary outcomes
Anxiety
Time frame: At enrolment, at the end of the 6th session of touch massage (1 session per week for 6 weeks) and 6 months after randomisation
Affect
Time frame: At enrolment, at the end of the 6th session of touch massage (1 session per week for 6 weeks), at 3 and 6 months after randomisation
Musculoskeletal disorders
Time frame: At enrolment, at the end of the 6th session of touch massage (1 session per week for 6 weeks), at 3 and 6 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch Massage in people with Quality of Life at Work and Paramedical Professionals, run by Institut Cancerologie de l'Ouest at 1 site in France.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Burn out (time frame: At enrolment and at the end of the 6th session of touch massage (1 session per week for 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025.