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

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.

• Traditional Chinese Medicine Body Acupuncture (Procedure): 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.

Primary outcomes

• Time to Target Recruitment [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 [During the 4-week intervention period.]: Proportion of participants completing the predefined acupuncture treatment schedule, including attendance and dropout rates.
• Organizational Feasibility [During the 4-week intervention period.]: Proportion of scheduled acupuncture sessions that are missed or cannot be performed as planned.
• Data Completeness and Quality [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 [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 [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).

Secondary outcomes

• Change in Burnout and Exhaustion [From baseline to end of intervention (Week 4) and end of follow-up (Week 8)]: Change in burnout and exhaustion measured using the Copenhagen Burnout Inventory (CBI).
• Change in Sleep Quality [From baseline to end of intervention (Week 4) and end of follow-up (Week 8)]: Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).
• Change in Wellbeing [From baseline to end of intervention (Week 4) and end of follow-up (Week 8)]: Change in subjective wellbeing measured using a visual analogue scale (VAS).

Other outcomes

• Incidence of Adverse Events [From the first acupuncture session through the end of follow-up (week 8)]: Number, type, and severity of adverse events occurring during the acupuncture intervention and follow-up period. Serious adverse events will also be recorded.
• Change in TCM Pulse Characteristics [Baseline, end of intervention (Week 4), and end of follow-up (Week 8).]: 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.

Sex: All, ages: 18 Years to any

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 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.)

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.)

• Daniel Franzen, Prof. Dr. med., Principal investigator, Spital Uster AG