Occupational Stress or Workplace StressTCM-ACU-PILOTNCT07818837
Feasibility of Body Acupuncture for Stress, Burnout, Sleep Quality and Wellbeing: A Pilot Study
A study testing Traditional Chinese Medicine Body Acupuncture in people with Occupational Stress or Workplace Stress and Exhaustion, Caregiver, run by Swiss University for Traditional Chinese Medicine at 1 site in Switzerland.
Trial summary
This pilot study investigates the acceptability and effects of traditional Chinese medicine (TCM) body acupuncture on stress and exhaustion among healthcare professionals working in an acute care hospital. Participants will receive acupuncture twice a week for four weeks, with a total of eight treatment sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Stress or Workplace Stress, Exhaustion, Caregiver
- What is being tested?
- Traditional Chinese Medicine Body Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employment as healthcare professional at the acute care hospital (Participants must be employed as a nurse, midwife, or physician at the acute care hospital.)
- Age ≥18 years
- Capacity to provide informed consent (Ability to understand the study information and provide written informed consent.)
- No known contraindications to acupuncture
- Moderate or higher subjective stress (Perceived Stress Scale (PSS-10) score of ≥14 at screening.)
- Availability for the intervention (Willingness and availability to attend two acupuncture sessions per week for four consecutive weeks.)
Who cannot join
- Pregnancy
- Inability to undergo acupuncture (Inability to consent to or tolerate acupuncture treatment, including severe needle phobia or severe coagulation disorder.)
- Nickel allergy
- Severe current psychiatric disorder or acute suicidality (Current diagnosis of a severe psychiatric disorder (e.g., severe depressive episode, bipolar disorder, or psychotic disorder), acute suicidality, or ongoing intensive psychiatric treatment.)
- Concurrent clinical intervention (Participation in another clinical intervention during the study period.)
- Language barriers (Language barriers that would prevent adherence to the study procedures or completion of the study questionnaires.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Spital Uster AG
Uster, Uster, 8610
Daniel Franzen, Prof. Dr. med., + 41 44 911 12 81, Daniel.Franzen@spitaluster.ch
About this study
Official title: Pilot Study on the Acceptability and Effects of Acupuncture on Stress and Exhaustion Among Healthcare Professionals at an Acute Care Hospital
This pilot study investigates the acceptability and effects of traditional Chinese medicine (TCM) body acupuncture on stress and exhaustion among healthcare professionals working in an acute care hospital. Participants will receive acupuncture twice a week for four weeks, with a total of eight treatment sessions. Stress, burnout, sleep quality, and general wellbeing will be assessed before and after the intervention and at follow-up. The study will also assess participants' satisfaction with the intervention and their willingness to participate again or recommend acupuncture to others. In addition, the feasibility of conducting the study will be evaluated, including recruitment, adherence to the treatment schedule, organizational feasibility, and completeness and quality of the collected data. The findings will help determine whether a larger clinical study of TCM body acupuncture in healthcare professionals is feasible and warranted.
Read the detailed description
This pilot study evaluates the acceptability, effects, and feasibility of traditional Chinese medicine (TCM) body acupuncture in healthcare professionals working in an acute care hospital.
Participants who meet the eligibility criteria and provide informed consent will receive a structured TCM body acupuncture intervention consisting of two 45-minute sessions per week for four consecutive weeks, for a total of eight sessions. The acupuncture treatment will be provided by qualified TCM therapists using sterile, disposable needles.
Participants will complete standardized questionnaires at baseline (T0), after the four-week intervention (T1), and at the end of a four-week follow-up period (T2). The assessments will include perceived stress, burnout/exhaustion, sleep quality, and general wellbeing. A TCM anamnesis and pulse assessment will be conducted at baseline. At follow-up assessments, participants will additionally report their satisfaction with the intervention and their willingness to participate in a similar intervention again or recommend it to others.
The feasibility of the study will be assessed using predefined criteria covering recruitment, adherence to the intervention, organizational feasibility, and completeness and quality of the collected data. Safety will be monitored throughout the study by recording adverse events and serious adverse events.
The study is designed as a pilot study and is intended primarily to assess whether the intervention and study procedures are acceptable and feasible and to provide preliminary information on changes in stress, exhaustion, sleep quality, and wellbeing. The results will inform the design and implementation of a potential larger controlled clinical study.
- Being tested
- Traditional Chinese Medicine Body Acupuncture
- Keywords
- Acupuncture, Traditional Chinese Medicine, Occupational Stress, Healthcare Professionals, Exhaustion, Burnout, Wellbeing, TCM
- Medical subject headings
- Occupational Stress, Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Body AcupunctureProcedure or surgery
Participants are assigned to one of two predefined treatment pathways based on standardized TCM syndrome differentiation, primarily using pulse diagnosis and TCM history, with tongue diagnosis when required. Participants with predominantly stress-related symptoms receive a stress-oriented dispersing protocol, while those with predominantly exhaustion-related symptoms receive an exhaustion-oriented tonifying protocol. In mixed presentations, assignment follows predefined diagnostic criteria, primarily based on pulse findings.
Both pathways use predefined acupuncture point combinations, with individualized adjustments permitted within the assigned pathway. Switching between pathways is not planned. The stress-oriented pathway uses 17 needles and the exhaustion-oriented pathway 16 needles.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Body Acupuncture | Other | Participants receive structured traditional Chinese medicine (TCM) body acupuncture twice weekly for four consecutive weeks. Each treatment session lasts approximately 45 minutes, resulting in a total of eight acupuncture sessions per participant. The intervention is administered by qualified TCM therapists using sterile, disposable acupuncture needles. Receives: Procedure: Traditional Chinese Medicine Body Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Target Recruitment
Time required to recruit the predefined target sample size.
Measured: From study start until the target sample size of 20 participants is reached, assessed up to 12 weeks.
Treatment Adherence
Proportion of participants completing the predefined acupuncture treatment schedule, including attendance and dropout rates.
Measured: During the 4-week intervention period.
Organizational Feasibility
Proportion of scheduled acupuncture sessions that are missed or cannot be performed as planned.
Measured: During the 4-week intervention period.
Data Completeness and Quality
Proportion of participants with complete and evaluable study data according to predefined data-quality criteria.
Measured: Baseline, end of intervention (Week 4), and end of follow-up (Week 8).
Participant Acceptability of the Acupuncture Intervention
Participants' subjective assessment of the acceptability of the acupuncture intervention using a 0-to-10 Visual Analogue Scale, with 0 indicating not at all acceptable and 10 indicating completely acceptable. Higher scores indicate greater acceptability
Measured: End of intervention (Week 4), and end of follow-up (Week 8).
Change in Perceived Stress
Change in perceived stress measured using the Perceived Stress Scale (PSS-10).
Measured: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Secondary outcomes (3)
Change in Burnout and Exhaustion
Change in burnout and exhaustion measured using the Copenhagen Burnout Inventory (CBI).
Measured: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Change in Sleep Quality
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).
Measured: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Change in Wellbeing
Change in subjective wellbeing measured using a visual analogue scale (VAS).
Measured: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Stress or Workplace StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss University for Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Franzen, Prof. Dr. med., Principal investigator, Spital Uster AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818837
- Sponsor's protocol ID
- STU-AKU-001
- Acronym
- TCM-ACU-PILOT
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Due to the small sample size and the potentially identifiable nature of the study population, individual-level data will not be made available for secondary research.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Acceptability and Effects of Acupuncture on Stress and Exhaustion Among Healthcare Professionals at an Acute Care Hospital
- ClinicalTrials.gov ID
- NCT07818837
- Acronym / sponsor ID
- TCM-ACU-PILOT / STU-AKU-001
- Keywords
- Acupuncture, Traditional Chinese Medicine, Occupational Stress, Healthcare Professionals, Exhaustion, Burnout, Wellbeing, TCM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Swiss University for Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study investigates the acceptability and effects of traditional Chinese medicine (TCM) body acupuncture on stress and exhaustion among healthcare professionals working in an acute care hospital. Participants will receive acupuncture twice a week for four weeks, with a total of eight treatment sessions. Stress, burnout, sleep quality, and general wellbeing will be assessed before and after the intervention and at follow-up. The study will also assess participants' satisfaction with the intervention and their willingness to participate again or recommend acupuncture to others. In addition, the feasibility of conducting the study will be evaluated, including recruitment, adherence to the treatment schedule, organizational feasibility, and completeness and quality of the collected data. The findings will help determine whether a larger clinical study of TCM body acupuncture in healthcare professionals is feasible and warranted.
Detailed description
This pilot study evaluates the acceptability, effects, and feasibility of traditional Chinese medicine (TCM) body acupuncture in healthcare professionals working in an acute care hospital.
Participants who meet the eligibility criteria and provide informed consent will receive a structured TCM body acupuncture intervention consisting of two 45-minute sessions per week for four consecutive weeks, for a total of eight sessions. The acupuncture treatment will be provided by qualified TCM therapists using sterile, disposable needles.
Participants will complete standardized questionnaires at baseline (T0), after the four-week intervention (T1), and at the end of a four-week follow-up period (T2). The assessments will include perceived stress, burnout/exhaustion, sleep quality, and general wellbeing. A TCM anamnesis and pulse assessment will be conducted at baseline. At follow-up assessments, participants will additionally report their satisfaction with the intervention and their willingness to participate in a similar intervention again or recommend it to others.
The feasibility of the study will be assessed using predefined criteria covering recruitment, adherence to the intervention, organizational feasibility, and completeness and quality of the collected data. Safety will be monitored throughout the study by recording adverse events and serious adverse events.
The study is designed as a pilot study and is intended primarily to assess whether the intervention and study procedures are acceptable and feasible and to provide preliminary information on changes in stress, exhaustion, sleep quality, and wellbeing. The results will inform the design and implementation of a potential larger controlled clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Body Acupuncture | Other | Procedure: Traditional Chinese Medicine Body AcupunctureParticipants receive structured traditional Chinese medicine (TCM) body acupuncture twice weekly for four consecutive weeks. Each treatment session lasts approximately 45 minutes, resulting in a total of eight acupuncture sessions per participant. The intervention is administered by qualified TCM therapists using sterile, disposable acupuncture needles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Employment as healthcare professional at the acute care hospital (Participants must be employed as a nurse, midwife, or physician at the acute care hospital.)
- Age ≥18 years
- Capacity to provide informed consent (Ability to understand the study information and provide written informed consent.)
- No known contraindications to acupuncture
- Moderate or higher subjective stress (Perceived Stress Scale (PSS-10) score of ≥14 at screening.)
Key exclusion criteria (6 listed)
- Pregnancy
- Inability to undergo acupuncture (Inability to consent to or tolerate acupuncture treatment, including severe needle phobia or severe coagulation disorder.)
- Nickel allergy
- Severe current psychiatric disorder or acute suicidality (Current diagnosis of a severe psychiatric disorder (e.g., severe depressive episode, bipolar disorder, or psychotic disorder), acute suicidality, or ongoing intensive psychiatric treatment.)
- Concurrent clinical intervention (Participation in another clinical intervention during the study period.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine Body AcupunctureParticipants are assigned to one of two predefined treatment pathways based on standardized TCM syndrome differentiation, primarily using pulse diagnosis and TCM history, with tongue diagnosis when required. Participants with predominantly stress-related symptoms receive a stress-oriented dispersing protocol, while those with predominantly exhaustion-related symptoms receive an exhaustion-oriented tonifying protocol. In mixed presentations, assignment follows predefined diagnostic criteria, primarily based on pulse findings. Both pathways use predefined acupuncture point combinations, with individualized adjustments permitted within the assigned pathway. Switching between pathways is not planned. The stress-oriented pathway uses 17 needles and the exhaustion-oriented pathway 16 needles. | Procedure or surgery | Traditional Chinese Medicine Body Acupuncture |
Primary outcome
Time to Target Recruitment
Time frame: From study start until the target sample size of 20 participants is reached, assessed up to 12 weeks.
Time required to recruit the predefined target sample size.
Treatment Adherence
Time frame: During the 4-week intervention period.
Proportion of participants completing the predefined acupuncture treatment schedule, including attendance and dropout rates.
Organizational Feasibility
Time frame: During the 4-week intervention period.
Proportion of scheduled acupuncture sessions that are missed or cannot be performed as planned.
Data Completeness and Quality
Time frame: Baseline, end of intervention (Week 4), and end of follow-up (Week 8).
Proportion of participants with complete and evaluable study data according to predefined data-quality criteria.
Participant Acceptability of the Acupuncture Intervention
Time frame: End of intervention (Week 4), and end of follow-up (Week 8).
Participants' subjective assessment of the acceptability of the acupuncture intervention using a 0-to-10 Visual Analogue Scale, with 0 indicating not at all acceptable and 10 indicating completely acceptable. Higher scores indicate greater acceptability
Change in Perceived Stress
Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Change in perceived stress measured using the Perceived Stress Scale (PSS-10).
3 secondary outcomes
Change in Burnout and Exhaustion
Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Change in Sleep Quality
Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Change in Wellbeing
Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Due to the small sample size and the potentially identifiable nature of the study population, individual-level data will not be made available for secondary research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Franzen, Prof. Dr. med. principal investigator
Spital Uster AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine Body Acupuncture in people with Occupational Stress or Workplace Stress and Exhaustion, Caregiver, run by Swiss University for Traditional Chinese Medicine at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Ineichen, PD Dr. sc. med. (+41 56 269 66 05, christian.ineichen@tcmuni.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Target Recruitment (time frame: From study start until the target sample size of 20 participants is reached, assessed up to 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.