ClinicalTrials.gg
Not yet recruitingNCT07818837TCM-ACU-PILOTUpdated Sep 14, 2026

Feasibility of Body Acupuncture for Stress, Burnout, Sleep Quality and Wellbeing: A Pilot Study

An interventional study of Traditional Chinese Medicine Body Acupuncture in Occupational Stress or Workplace Stress and Exhaustion, Caregiver, sponsored by Swiss University for Traditional Chinese Medicine. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Swiss University for Traditional Chinese Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Occupational Stress or Workplace Stress
  • Exhaustion, Caregiver

Keywords

  • Acupuncture
  • Traditional Chinese Medicine
  • Occupational Stress
  • Healthcare Professionals
  • Exhaustion
  • Burnout
  • Wellbeing
  • TCM
03

In context

Occupational Stress

236 studies on the registry are indexed under Occupational Stress; 63 are open to participants now.

This study's planned enrollment of 20 is below the median of 84 across 168 interventional studies indexed under Occupational Stress.

Browse Occupational Stress studies →

Lead sponsor

This is the only study on the registry with Swiss University for Traditional Chinese Medicine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (Ability to understand the study information and provide written informed consent.)
  • No known 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.)

Exclusion criteria

Exclusion Criteria:

  • 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.)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Traditional Chinese Medicine Body Acupuncture

    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.

    Procedure: Traditional Chinese Medicine Body Acupuncture

Interventions

  • ProcedureTraditional Chinese Medicine Body Acupuncture

    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.

06

What researchers measure

Primary outcomes

  1. Time to Target Recruitment

    Time required to recruit the predefined target sample size.

    Time frame: From study start until the target sample size of 20 participants is reached, assessed up to 12 weeks.

  2. Treatment Adherence

    Proportion of participants completing the predefined acupuncture treatment schedule, including attendance and dropout rates.

    Time frame: During the 4-week intervention period.

  3. Organizational Feasibility

    Proportion of scheduled acupuncture sessions that are missed or cannot be performed as planned.

    Time frame: During the 4-week intervention period.

  4. Data Completeness and Quality

    Proportion of participants with complete and evaluable study data according to predefined data-quality criteria.

    Time frame: Baseline, end of intervention (Week 4), and end of follow-up (Week 8).

  5. 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

    Time frame: End of intervention (Week 4), and end of follow-up (Week 8).

  6. Change in Perceived Stress

    Change in perceived stress measured using the Perceived Stress Scale (PSS-10).

    Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)

Secondary outcomes

  1. Change in Burnout and Exhaustion

    Change in burnout and exhaustion measured using the Copenhagen Burnout Inventory (CBI).

    Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)

  2. Change in Sleep Quality

    Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).

    Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)

  3. Change in Wellbeing

    Change in subjective wellbeing measured using a visual analogue scale (VAS).

    Time frame: From baseline to end of intervention (Week 4) and end of follow-up (Week 8)

Other outcomes

  1. Incidence of Adverse Events

    Number, type, and severity of adverse events occurring during the acupuncture intervention and follow-up period. Serious adverse events will also be recorded.

    Time frame: From the first acupuncture session through the end of follow-up (week 8)

  2. Change in TCM Pulse Characteristics

    Change in predefined TCM pulse characteristics, including wiry, weak, and slippery pulse patterns, assessed using standardized pulse diagnosis and predefined grading criteria. A change of two grading levels is considered clinically meaningful.

    Time frame: Baseline, end of intervention (Week 4), and end of follow-up (Week 8).

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.

Of 125 non-industry interventional studies with no phase under Occupational Stress, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 28. This study's planned 6 months is below that.

Counting every sponsor, half of 133 studies reached it within 10 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 14, 2026
StartEst.
Dec 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07818837
Lead sponsor
Swiss University for Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Christian Ineichen, PD Dr. sc. med.
Contact
christian.ineichen@tcmuni.ch
+41 56 269 66 05
Daniel Franzen, Prof. Dr. med.
Contact
Daniel.Franzen@spitaluster.ch
+ 41 44 911 12 81
Daniel Franzen, Prof. Dr. med.
principal investigator · Spital Uster AG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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