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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

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Do Videos That Aim to Optimize Expectations Alter the Effectivess of PMR?
Official Title  ICMJE Effects of Videos Aiming to Optimize Expectations on Effectiveness of Progressive Muscle Relaxation (PMR)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Experimental Group 1 (Video Personal Expert)
  • Experimental Group 2 (Video Factual Expert)
  • Control Group
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Progressive Muscle Relaxation (PMR)
  • 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.
    Intervention: Behavioral: Progressive Muscle Relaxation (PMR)
  • Active Comparator: Control group
    Participants read a neutral text before undergoing a Progressive Muscle Relaxation (PMR) session.
    Intervention: Behavioral: Progressive Muscle Relaxation (PMR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic illness
  • Mental disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330431
Other Study ID Numbers  ICMJE 2017_EXPECT_v1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Winfried Rief, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Winfried Rief, Professor Philipps Universität Marburg
PRS Account Philipps University Marburg Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP