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Verbal suggestion and relaxation


- candidate number27088
- NTR NumberNTR6392
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2017
- Secondary IDsCEP16-0728/261 CEP Leiden University
- Public TitleVerbal suggestion and relaxation
- Scientific TitleThe role of a verbal suggestion in coping with acute stress after relaxation exercises
- ACRONYMVerbal suggestion and relaxation
- hypothesisThe aim of the study is to investigate whether a verbal suggestion concerning the relaxation exercises alone or in combination with actually performing relaxation exercises can alter self-reported stress and psychophysiological measurements of stress after an social-evaluation task as an acute stressor.
- Healt Condition(s) or Problem(s) studiedVerbal suggestion, Acute stress response, Relaxation
- Inclusion criteria1. Between 18 and 35 years old
2. Good understanding of written and spoken Dutch
- Exclusion criteria1. Severe psychological and/or somatic conditions
2. Regular alcohol use (> 3 units a day)
3. Current or recent life events ( 3 months ago)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-mrt-2017
- planned closingdate31-dec-2017
- Target number of participants120
- InterventionsThis randomized controlled experiment involves four conditions, in which: (1) a verbal suggestion considering the effectiveness and working mechanisms of relaxation exercises is provided, without performing the relaxation exercises, (2) relaxation exercises are performed and a verbal suggestion considering the effectiveness and working mechanisms of relaxation exercises is provided, (3) relaxation exercises are performed without providing a verbal suggestion, and (4) puzzles were performed in a control condition.
- Primary outcomeThe primary study outcome is self-reported state anxiety, as measured by the 6-item Shortened State-Trait Anxiety Inventory State version.
- Secondary outcome1. Self-reported psychological outcome measures
2. Heart rate and skin conductance
3. Cortisol and alpha amylase
- TimepointsFirst, participants are screened through an online questionnaire in order to check the eligibility criteria. When they are eligible to take part in the study, they are invited to one lab session. During the lab session, participants complete questionnaires, a resting measurement of their heart rate and skin conductance is performed, and cortisol and alpha amylase measures are taken. They are then randomized to one of the four conditions as described above.
Subsequently, participants perform the social-evaluation stress task, the Trier Social Stress Test. After 10 and 20 minutes upon completion of the Trier Social Stress Test, they again have to complete several questionnaires, resting measurement and saliva sample on three subsequent time points. At the end, they are debriefed about the actual purpose of the study.
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. A.W.M. Evers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.W.M. Evers
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
European Research Council Consolidator Grant
- Publicationsn/a
- Brief summaryPrior research demonstrated that relaxation exercises can alleviate stress responses after an acute stressor. The underlying effective mechanisms of relaxation exercises are, however, not yet clear. No studies up till now have examined whether acute stress could also be optimized when participants do not perform the relaxation exercises, but are solely instructed about the effectiveness and actions of the relaxation exercises. Therefore, in the present study it is investigated whether a verbal suggestion considering the effectiveness and working mechanisms of relaxation exercises can alleviate stress responses after an acute stressor.
- Main changes (audit trail)
- RECORD13-apr-2017 - 21-jun-2017


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