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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Traditional Chinese Medicine Body Acupuncture
Procedure/SurgeryParticipants 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
Trial outcomes
Primary outcomes
Time to Target Recruitment
Time required to recruit the predefined target sample size.
Treatment Adherence
Proportion of participants completing the predefined acupuncture treatment schedule, including attendance and dropout rates.
Organizational Feasibility
Proportion of scheduled acupuncture sessions that are missed or cannot be performed as planned.
Data Completeness and Quality
Proportion of participants with complete and evaluable study data according to predefined data-quality criteria.
Secondary outcomes
Change in Burnout and Exhaustion
Change in burnout and exhaustion measured using the Copenhagen Burnout Inventory (CBI).
Change in Sleep Quality
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).
Change in Wellbeing
Change in subjective wellbeing measured using a visual analogue scale (VAS).
Other outcomes
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.
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.
Sponsors and contacts
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