Clinical trial NCT06795594: Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery
Official title: Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture Analgesia
Keywords: Cheek acupuncture therapy
Acupuncture
Cesarean delivery
Pain control
Postoperative pain management
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and explores its mechanisms of action through a prospective randomized controlled clinical trial.

Detailed description: Pain control after cesarean delivery, if inadequately managed, can impact the prognosis of the mother and the health of the infant. There is an urgent need to explore safer, more effective, and straightforward non-pharmacological adjunctive interventions to alleviate the pain associated with cesarean section. Cheek acupuncture therapy is a green micro-acupuncture treatment that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. To practice the concept of perioperative acupuncture medicine, this study aims to investigate whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and to explore the mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III.
2. Scheduled for elective cesarean delivery under spinal anesthesia.
3. Patients are aged between 19 to 45 years old.
4. Patients have provided written informed consent.

Exclusion Criteria:

1. Local skin infection at the acupuncture sites in the cheek area.
2. Cases where spinal anesthesia fails and general anesthesia is required.
3. Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure.
4. Patients who have used opioid medications at least 6 months prior to surgery.
5. Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments.
6. Patients with a history of psychiatric illness.

Primary outcomes:
measure: Numeric Rating Scale (0-10) pain score during movement
timeFrame: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment
Secondary outcomes:
measure: the proportion of patients with NRS pain score ≥ 6
timeFrame: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment
measure: NRS pain score during movement
timeFrame: morning of the day of discharge (assessed up 7 days)
measure: The Hospital Anxiety and Depression Scale (HADS)-A
timeFrame: morning of the day of discharge (assessed up 7 days)
measure: HADS-D score
timeFrame: morning of the day of discharge (assessed up 7 days)
measure: ISI score
timeFrame: morning of the day of discharge (assessed up 7 days)
measure: QoR15 score
timeFrame: morning of the day of discharge (assessed up 7 days)
measure: HCRP
timeFrame: 48 hours postoperatively
measure: Beta-endorphin
timeFrame: 48 hours postoperatively
measure: Postoperative adverse reactions
timeFrame: From date of randomization until the date of discharge, assessed up to 7 days
measure: Postoperative severe complications
timeFrame: From date of randomization until the date of discharge, assessed up to 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tongren Hospital
name: Guyan Wang
role: STUDY_DIRECTOR
References: