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Do Videos That Aim to Optimize Expectations Alter the Effectivess of PMR?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330431
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Experimental Group 1 (Video Personal Expert) Experimental Group 2 (Video Factual Expert) Control Group Behavioral: Progressive Muscle Relaxation (PMR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Videos Aiming to Optimize Expectations on Effectiveness of Progressive Muscle Relaxation (PMR)
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : November 30, 2017

Arm Intervention/treatment
Experimental: Experimental group 1 (personal expert)
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)

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.


Experimental: Experimental group 2 (factual expert)
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)

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.


Active Comparator: Control group
Participants read a neutral text before undergoing a Progressive Muscle Relaxation (PMR) session.
Behavioral: Progressive Muscle Relaxation (PMR)

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.





Primary Outcome Measures :
  1. Change in perceived/subjective relaxation [ Time Frame: Change from pre (baseline) to post scores (30 minutes later) ]
    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).


Secondary Outcome Measures :
  1. Change in perceived stress [ Time Frame: Change from pre (baseline) to post scores (30 minutes later) ]
    Participants are asked to rate how stressed they feel at the moment at two time points (baseline and after the PMR intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores).

  2. Change in physiological relaxation [ Time Frame: Change from pre (baseline) to post scores (30 minutes later) ]
    Electromyography is used to assess participants' physiological relaxation status at baseline and after the PMR intervention. Change scores are calculated (post- minus pre-scores).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic illness
  • Mental disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330431


Locations
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Germany
Department of Psychology, Philipps University Marburg
Marburg, Hessen, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Winfried Rief, Professor Philipps Universität Marburg
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Responsible Party: Winfried Rief, Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03330431    
Other Study ID Numbers: 2017_EXPECT_v1
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No