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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss University for Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

  • Traditional Chinese Medicine Body Acupuncture

    Procedure/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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Traditional Chinese Medicine Body AcupunctureOther 1 intervention

Trial outcomes

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).

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).

Sponsors and contacts

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