Pilot randomized-controlled trial on the efficacy of acupuncture in people with an increased stress level
| ISRCTN | ISRCTN15259166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15259166 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/08/2017
- Registration date
- 18/09/2017
- Last edited
- 11/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
It is well known that chronic (long-term) stress is a risk factor or intensifier for a variety of physical disorders or illnesses. Chronic stress has been demonstrated to increase cardiovascular (heart disease) risks, musculoskeletal disorders, and mental disorders such as depression. In Traditional Chinese Medicine acupuncture has been used to treat stress-related disorders. First studies have shown that acupuncture may serve as an adequate treatment for people with increased stress. However, well-designed studies demonstrating the effectiveness of acupuncture in chronic stress are still lacking. This study aims to assess the feasibility and acceptability of acupuncture in people with an increased stress level.
Who can participate?
Healthy adults aged 18 and over with an increased stress level
What does the study involve?
At the beginning of the study a diagnostic assessment is carried out for all participants. Afterwards participants are randomly allocated to one of three groups. One group receives verum (true) acupuncture treatment, one group sham acupuncture, and one group is put on a waiting list. Stress is measured at the start of the study, at the end of treatment and at three months after the end of treatment.
What are the possible benefits and risks of participating?
All participants are assessed closely by a professional team at the start of the study. Participants of all groups may benefit from the acupuncture treatment. Participation in this study involves no risks of physical injury or harm.
Where is the study run from?
University Hospital Heidelberg (Germany)
When is the study starting and how long is it expected to run for?
August 2017 to August 2018
Who is funding the study?
1. University Hospital Heidelberg (Germany)
2. Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg (Germany)
Who is the main contact?
Prof. Beate Wild
Contact information
Scientific
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
Study information
| Study design | Randomized controlled three-armed pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Pilot randomized-controlled trial on the efficacy of acupuncture in people with an increased stress level |
| Study acronym | AkuRest |
| Study objectives | This pilot study aims to assess the feasibility and acceptability of the study design and treatment. Study hypotheses: 1. 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 the included persons complete the study. 2. Explorative: The acupuncture intervention leads to a reduction of the stress level measured by using the Perceived Stress Questionnaire (PSQ-20) and the Patient Health Questionnaire (PHQ stress module). 3. Explorative: Acupuncture leads to alterations in psychoneuroimmunologic and psychophysiologic parameters. |
| Ethics approval(s) | Ethics Committee of the University of Heidelberg, 12/05/2017, ref: S-011/2017 |
| Health condition(s) or problem(s) studied | Adults with high self-reported stress levels |
| Intervention | At the beginning of the study a diagnostic assessment is done for all participants. Afterwards participants are randomized to one out of three groups. The randomization will conducted by using the randomization software “RANDI 2”. Randomization will be stratified by center. The randomization program will be applied by an independent assistant at the University Hospital Heidelberg. 1. Verum acupuncture group. The indicated points of the verum acupuncture are predefined according to literature research and the expertise of the acupuncturist and will be maintained throughout the 10 sessions. Eliciting a De Qi sensation is the aim of the treatment. The individual points may be chosen and altered during the course of treatment by the acupuncturist according to the leading clinical symptoms. 2. Sham acupuncture group. 4-6 standardized points of acupuncture are chosen that are not on acupuncture meridians. These will only be placed superficially without eliciting a so-called De Qi sensation. The control acupuncture points may analogous to the verum acupuncture be changed individually during the course of treatment. 3. Waiting list control group: a group that will, to begin with, not be treated for 3 months. The intervention consists of 10 sessions (each between 20-30 minutes). Acupuncture will be carried out by a licensed acupuncturist. Intervals between treatments are dependent on the participant and according to plan and feasibility between 3 and 7 days. The total duration of treatment will be up to three months. There will be a follow-up measurement at about three months after the end of treatment. |
| Intervention type | Other |
| Primary outcome measure | 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 | 1. Stress level, measured by the PSQ-20, the PSS, and the PHQ stress module 2. Heart rate variability, measured at all three centers with the same device using a standardized protocol 3. Psychoneuroimmunologic parameters, analysed using blood samples Measured at baseline (at the beginning of the study), end of treatment, and at three months follow-up |
| Overall study start date | 28/08/2017 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. PSQ-20 score ≥ 60 2. Age ≥ 18 3. Written informed consent |
| Key exclusion criteria | 1. Suicidal ideation 2. Psychiatric disorder 3. Needle phobia 4. Insufficient knowledge of the German language |
| Date of first enrolment | 31/08/2017 |
| Date of final enrolment | 15/06/2018 |
Locations
Countries of recruitment
- Germany
Study participating centres
Heidelberg
69120
Germany
72076
Germany
79106
Germany
69120
Germany
Sponsor information
Hospital/treatment centre
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
"ROR" |
https://ror.org/013czdx64 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Government organisation / Local government
- Alternative name(s)
- Ministry of Science, Research and Art Baden-Württemberg, MWK
- Location
- Germany
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The German study protocol is available upon request. The trialists intend to publish the study results in a high-impact journal at about 6 months after the end of the study. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/07/2020 | 22/09/2020 | Yes | No |
| Dataset | 11/10/2023 | No | No |
Editorial Notes
11/10/2023: Link to dataset added to outputs table.
22/09/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
09/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2018 to 15/06/2018.
2. The overall trial end date was changed from 31/08/2018 to 31/12/2018.
3. The intention to publish date was changed from 28/02/2019 to 31/12/2019.
