Pilot randomized-controlled trial on the efficacy of acupuncture in people with an increased stress level
Not Applicable
Completed
- Conditions
- Adults with high self-reported stress levelsMental and Behavioural Disorders
- Registration Number
- ISRCTN15259166
- Lead Sponsor
- niversity Hospital Heidelberg
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32701984/ results (added 22/09/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
1. PSQ-20 score = 60
2. Age = 18
3. Written informed consent
Exclusion Criteria
1. Suicidal ideation
2. Psychiatric disorder
3. Needle phobia
4. Insufficient knowledge of the German language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and acceptability: defined as the study design is well accepted by those persons meeting the inclusion criteria, the rate of persons consenting to participation is over 50% and more than 70% of these complete the study. Measured at the end of treatment.
- Secondary Outcome Measures
Name Time Method <br> 1. Stress level, measured by the PSQ-20, the PSS, and the PHQ stress module<br> 2. Heart rate variability, measured at all three centers with the same device using a standardized protocol<br> 3. Psychoneuroimmunologic parameters, analysed using blood samples<br><br> Measured at baseline (at the beginning of the study), end of treatment, and at three months follow-up<br>