Effects of music regulation and combined mind-body intervention in the prisoner population
| ISRCTN | ISRCTN10402129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10402129 |
| Sponsor | Shenzhen University |
| Funder | National Natural Science Foundation of China |
- Submission date
- 13/10/2026
- Registration date
- 13/10/2026
- Last edited
- 13/10/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People in prison often experience high stress, anxiety, low mood and poor sleep, which can affect their wellbeing and behaviour. Listening to relaxing music and practising simple mind-body techniques such as guided relaxation, breathing and gentle stretching are low-cost, safe and easy to deliver, but little is known about whether they help in a prison setting, either alone or combined. This study aims to find out whether music and mind-body practices improve mood and sleep among people in prison, and whether using both together works better than either one alone.
Who can participate?
Adults aged 18 to 65 held in the participating prison who have at least 7 months of their sentence remaining, can read and understand Chinese questionnaires, and agree to take part in writing. People with serious self-reported physical or mental-health conditions, or who are due for parole, release or transfer within the next 7 months, cannot take part.
What does the study involve?
Four prison districts take part, and each is assigned to one of four arrangements that continue throughout the study: daily routine as usual, music practice only, mind-body practice only, or both music and mind-body practice. The practices are fitted into the normal prison day and include short guided relaxation or mindfulness audio with relaxing music, gentle stretching during work breaks, and a brief bedtime practice in some groups. In the first week everyone completes baseline questionnaires (about 20 minutes); the same questionnaires are repeated in weeks 6, 11 and 16. Participation is voluntary and anyone can stop at any time without penalty.
What are the possible benefits and risks of participating?
Participants may learn simple relaxation skills, receive brief feedback on their own stress and sleep, and help build healthier prison routines. Risks are minor: mild muscle tiredness or brief emotional discomfort during relaxation. There are no drugs, injections, devices or invasive procedures."[
Where is the study run from?
The School of Psychology, Shenzhen University, China.
When is the study starting and how long is it expected to run for?
It starts in October 2026; the active programme in the prison lasts 16 weeks, and the whole study is expected to finish around October 2027.
Who is funding the study?
This study is funded by the National Natural Science Foundation of China (NSFC).
Who is the main contact?
Dr Jieting Zhang, School of Psychology, Shenzhen University, jenny121@126.com
Contact information
Principal investigator
Shenzhen University
Shenzhen
518060
China
| Phone | +86 135 10483902 |
|---|---|
| Jenny121@126.com |
Public, Scientific
Shenzhen University
Shenzhen
518060
China
| Phone | +86 18089387521 |
|---|---|
| zhangrtcufe@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Uncontrolled |
| Assignment | Crossover |
| Purpose | Health services research, Prevention |
| Participant information sheet | 50444 (in Chinese).pdf |
| Scientific title | Effects of music regulation and combined mind-body intervention in the prisoner population |
| Study objectives | To evaluate the effects of music regulation, mind-body regulation, and their combined intervention on improving emotional problems among prisoners, and to further examine the added benefit of music regulation on the outcomes of the mind-body regulation intervention. To explore the psychological mechanisms by which music regulation and mind-body regulation interventions improve emotional wellbeing and sleep, thereby providing a basis for establishing a long-term intervention model suitable for routine management in prison settings. |
| Ethics approval(s) |
Approved 22/09/2026, Human Research Ethics Committee for Non-Clinical Faculties (Shenzhen University, Shenzhen, 518060, China; +86 755 2691 7503; zuyanan@szu.edu.cn), ref: SZU_PSY_2026_082 |
| Health condition(s) or problem(s) studied | Psychological stress, anxiety and depression symptoms, and emotional problems among incarcerated adults |
| Intervention | Design and arms: This is a cluster randomised controlled trial with prison districts (wards) as the unit of randomisation. Four prison districts are allocated to one of four parallel arms: (1) no-treatment control receiving routine prison management only; (2) music regulation; (3) mind-body regulation; (4) combined music and mind-body regulation. Interventions: Music regulation uses relaxing music. Mind-body regulation uses a neutral, text-guided mindfulness/body-scan audio (containing no emotion-inducing or traumatic material), together with gentle stretching exercise breaks during the daily routine and a brief bedtime practice in selected groups; the combined arm receives both. Sessions are delivered within the usual prison management framework by designated playback operators, and prison officers record only the audio codes. The control district continues routine management without the study interventions. Randomisation and allocation concealment: An independent statistician generates the randomisation sequence by computer; the sequence is kept sealed and is revealed only after enrolment and baseline assessment of each prison district are completed. Schedule: The study lasts 16 weeks. Week 1 is baseline assessment; the intervention begins in week 2, and the same assessments are repeated for all participants at weeks 6, 11 and 16. Each participant completes paper-based questionnaires (about 20 minutes) at the participating prison. Blinding: Outcome assessors (questionnaires) are unaware of group allocation; data-entry and statistical-analysis personnel access only de-identified data and group codes. Because the interventions are identifiable, playback operators know their own district's content but take no part in outcome assessment and do not explain allocation; prison officers record only audio codes and are not informed of the specific intervention. Daily diary (process measure): In addition to the scheduled questionnaires, participants complete a short daily paper diary recording sleep and mood, which is collected weekly. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/10/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target sample size at registration | 560 |
| Total final enrolment | 560 |
| Key inclusion criteria | 1. Chinese adults aged 18 to 65 years (including young and middle-aged adults) detained in one of the four participating prison districts of the participating prison 2. Able to understand the questionnaire content and to complete paper-based assessments independently 3. Willing to participate voluntarily and having signed the informed consent form |
| Key exclusion criteria | 1. Major physical or mental-health conditions, ascertained through prison records and self-report 2. Less than 7 months of remaining sentence 3. Scheduled for parole or transfer out of the prison district within the following 7 months |
| Date of first enrolment | 19/10/2026 |
| Date of final enrolment | 20/10/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 13/10/2026 | No | Yes |
Additional files
- 50444 (in Chinese).pdf
- Participant information sheet
Editorial Notes
13/10/2026: Trial's existence confirmed by Shenzhen University.
