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)") (PauseTM)

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]:

• 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 Overview

• Status: Active, not recruiting
• Conditions: Quality of Life at Work; Paramedical Professionals; Touch Massage; Cancer Center
• Intervention / Treatment: Other: Touch Massage

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint HERBLAIN, France, 44805
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Touch massage; Participants receive 6 Touch Massage sessions, given once a week for 6 weeks by one of the Touch Massage practitioners	Other: Touch Massage; 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.
No Intervention: Without Touch massage; Participants will not receive any Touch Massage sessions for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At enrolment and at the end of the 6th session of touch massage (1 session per week for 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): May 2, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; stress; well-being; affect; burnout; musculoskeletal disorders
• Other Study ID Numbers: ICO-2023-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No