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Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention

Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04973839
Enrollment
90
Registered
2021-07-22
Start date
2021-07-07
Completion date
2021-09-15
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention).

Detailed description

This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR session compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention). After the baseline assessment, participants are randomized to one of 4 possible intervention groups: i) watching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided), ii) watching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided), iii) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided), or iv) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided). In a pre-posttest design, the subjective stress levels of the participants in the for groups will be analyzed.

Interventions

BEHAVIORALVideo optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR)

Participants watch a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided). The PMR session 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.

BEHAVIORALVideo optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR)

Participants watch a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided). The PMR session 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.

BEHAVIORALNeutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR)

Participants watch a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided). The PMR session 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.

BEHAVIORALNeutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR)

Participants watch a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided).The PMR session 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.

Sponsors

Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness * Mental disorder

Design outcomes

Primary

MeasureTime frameDescription
Change in perceived stressChange 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). More negative change scores are better since it indicates a stronger stress reduction (maximum reduction: -100). Higher positive change scores are worse since this indicates an increase in perceived stress (maximum increase: +100). Range of change scores: -100 - +100).

Secondary

MeasureTime frameDescription
Change in positive affectChange from pre (baseline) to post scores (30 minutes later)Participants are asked to rate adjectives regarding their current mood (positive and negative) at two time points (baseline and after the PMR intervention) on a questionnaire. Change scores are calculated (post- minus pre-scores). Instrument: Positive and Negative Affect Scale (PANAS) by Watson, Clark, and Tellegen (1988) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range for sum score of positive/negative affect: 10-50. For positive affect higher scores are better; for negative affect lower scores are better.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026