NCT03330431

Brief Summary

The study's aim is to determine whether a short video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) ist able to improve the actual effectiveness of PMR in comparison with a neutral (no video) control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

September 27, 2017

Last Update Submit

July 1, 2020

Conditions

Experimental Group 1 (Video Personal Expert)Experimental Group 2 (Video Factual Expert)Control Group

Outcome Measures

Primary Outcomes (1)

  • Change in perceived/subjective relaxation

    Participants are asked to rate how relaxed they feel at the moment at two time points (baseline and after the PMR intervention) on a questionnaire (VAS: item ranges from 0 (not relaxed at all) - 100 (very relaxed). Change scores are calculated (post- minus pre-scores).

    Change from pre (baseline) to post scores (30 minutes later)

Secondary Outcomes (2)

  • Change in perceived stress

    Change from pre (baseline) to post scores (30 minutes later)

  • Change in physiological relaxation

    Change from pre (baseline) to post scores (30 minutes later)

Study Arms (3)

Experimental group 1 (personal expert)

EXPERIMENTAL

Participants watch a video of an expert describing the positive effects of Progressive Muscle Relaxation (PMR) with personalized examples and stories before undergoing a PMR session.

Behavioral: Progressive Muscle Relaxation (PMR)

Experimental group 2 (factual expert)

EXPERIMENTAL

Participants watch a video of an expert describing the positive effects of Progressive Muscle Relaxation (PMR) with factual information (not personal) before undergoing a PMR session.

Behavioral: Progressive Muscle Relaxation (PMR)

Control group

ACTIVE COMPARATOR

Participants read a neutral text before undergoing a Progressive Muscle Relaxation (PMR) session.

Behavioral: Progressive Muscle Relaxation (PMR)

Interventions

Progressive Muscle Relaxation (PMR)BEHAVIORAL

All groups undergo a PMR session, but they differ regarding the treatment before the PMR session. Two groups watch a video before undergoing PMR, the control group reads a text before undergoing PMR. Progressive muscle relaxation (PMR) is a technique for learning to monitor and control the state of muscular tension. It was developed by American physician Edmund Jacobson in the early 1920s. The technique involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.

Control groupExperimental group 1 (personal expert)Experimental group 2 (factual expert)

Eligibility Criteria

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

You may qualify if:

  • Healthy participants
  • fluency in the German language to provide informed consent

You may not qualify if:

  • Chronic illness
  • Mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Location

Related Publications (1)

  • Salzmann S, Wilhelm M, Schindler S, Rief W, Euteneuer F. Optimising the efficacy of a stress-reducing psychological intervention using placebo mechanisms: A randomized controlled trial. Stress Health. 2022 Oct;38(4):722-735. doi: 10.1002/smi.3128. Epub 2022 Jan 24.

    PMID: 35043534DERIVED

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Winfried Rief, Professor

    Philipps Universität Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 27, 2017

First Posted

November 6, 2017

Study Start

July 1, 2017

Primary Completion

September 15, 2017

Study Completion

November 30, 2017

Last Updated

July 2, 2020

Record last verified: 2020-07

Locations

DE(1)