NCT06928987

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

November 5, 2024

Last Update Submit

April 8, 2025

Conditions

Keywords

burnoutstressanxietyaffectmusculoskeletal disorderswell-being

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    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

    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

Study Arms (2)

Touch massage

EXPERIMENTAL

Participants receive 6 Touch Massage sessions, given once a week for 6 weeks by one of the Touch Massage practitioners

Other: Touch Massage

Without Touch massage

NO INTERVENTION

Participants will not receive any Touch Massage sessions for the duration of the study.

Interventions

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.

Touch massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Burnout, PsychologicalAnxiety DisordersMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

April 15, 2025

Study Start

May 16, 2024

Primary Completion

May 2, 2025

Study Completion

July 1, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations