Acupressure, Postoperative Pain, Postpartum Anxiety
Conditions
Keywords
Acupressure, Cesarean Section, Anxiety, Postoperative Pain, LI4, PC6, SP6
Brief summary
The goal of this clinical trial is to evaluate whether acupressure combined with standard post-operative modern medical care can reduce pain and anxiety in postpartum women after cesarean delivery under spinal anesthesia. The main questions it aims to answer are: * Does acupressure combined with standard care reduce post-cesarean pain more effectively than sham acupressure with standard care? * Does the combined approach reduce post-cesarean anxiety levels more effectively than sham acupressure with standard care? * What adverse effects may occur in participants receiving acupressure? Researchers will compare acupressure combined with standard care to sham acupressure combined with standard care to determine whether the active intervention provides additional benefits. Participants will: * Receive acupressure (or sham acupressure at non-therapeutic points) for 3 days. * Receive standard post-operative modern medical pain management and care as prescribed by the hospital. * Be assessed for pain (VAS-P) and anxiety (VAS-A, STAI-Y1) at baseline (before intervention) and after 3 days of intervention.
Detailed description
This randomized, single-blind, controlled clinical trial aims to evaluate the effectiveness and safety of acupressure combined with standard modern care in postpartum women with pain and anxiety following cesarean delivery under spinal anesthesia. Participants who meet the eligibility criteria will be randomly assigned to either the intervention group ( acupressure plus standard modern care) or the control group (sham acupressure plus standard modern care). In the intervention group, participants will receive manual acupressure (using xoa, day, and an techniques) on three bilateral therapeutic points: Hegu (LI4), Neiguan (PC6), and Sanyinjiao (SP6). Before applying pressure, the surrounding tissue is rubbed (xoa) with the palm for 20-30 seconds. Then, the points are pressed (an) for 5 seconds at a depth of 1-1.5 cm, kneaded (day) for 5 seconds, and rested for 5 seconds, repeating this cycle for 2 minutes per point. The total duration is 15 minutes for 6 points, performed once daily for 3 consecutive days. In the control group, participants will receive sham acupressure (xoa, day, an) at identical frequencies and durations on 3 non-therapeutic sham points: Sham Hegu, Sham Neiguan, and Sham Sanyinjiao. Both groups will receive standard post-operative modern pain management as prescribed by the hospital's obstetricians, which includes: * Post-op Day 1: Paracetamol 1g IV q6-8h ± Diclofenac 100mg rectally q12h; * Post-op Day 2 onwards: Paracetamol 1g PO q8h ± Diclofenac 100mg rectally q12h or other NSAIDs (such as Diclofenac 50mg, Ibuprofen 600-1200mg/day, Paracetamol + Ibuprofen, or Paracetamol + Tramadol) as prescribed by the hospital. Outcomes including pain (VAS-P), anxiety (VAS-A, STAI-Y1), and any adverse events will be assessed at baseline (T1, pre-intervention) and after 3 days of intervention (T2).
Interventions
PROCEDUREAcupressure
Manual massage and acupressure using techniques of rubbing (xoa) for 20-30 seconds, followed by pressing (an) for 5 seconds, kneading (day) for 5 seconds, and resting for 5 seconds, repeating for 2 minutes per point. A total of 15 minutes for 6 bilateral points (Hegu \[LI4\], Neiguan \[PC6\], Sanyinjiao \[SP6\]) will be performed once daily for 3 consecutive days. All procedures will be performed by a licensed traditional medicine physician following standardized protocols.
PROCEDURESham Acupressure
Sham acupressure using identical techniques (xoa, day, an), duration (3 days), and instructions at 3 bilateral non-therapeutic points: Sham Hegu (on the back of the hand, 1 thon from the midpoint between index and middle fingers), Sham Neiguan (inner forearm, 2 thon from wrist crease and 1.5 thon towards the radial side), and Sham Sanyinjiao (3 thon above the medial malleolus, then 1.5 thon posterior on the Achilles tendon). All procedures will be performed by a licensed traditional medicine physician.
BEHAVIORALStandard care
Standard post-operative modern pain management of the hospital: Post-op Day 1: Paracetamol 1g IV q6-8h ± Diclofenac 100mg rectally q12h; Post-op Day 2 onwards: Paracetamol 1g PO q8h ± Diclofenac 100mg rectally q12h or other NSAIDs as prescribed.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postpartum women aged 18 years or older who have undergone cesarean delivery with spinal anesthesia. * Gestational age \>= 37 weeks. * Willing to participate and signing the written informed consent form.
Exclusion criteria
* General anesthesia or methods other than spinal anesthesia. * Hearing, vision, or speech impairment. * History of chronic diseases such as uncontrolled diabetes, severe hypertension, cardiovascular disease, or psychiatric disorders. * Diagnosed with chronic pain before surgery, or regular use of pain medications. * Opioid, alcohol addiction or dependence. * Pathological cesarean deliveries (placenta praevia, placental abruption, placenta accreta). * Multiple pregnancies (twins, triplets, etc.). * Post-operative complications (wound infection, hemorrhage, coagulation disorders, or loss of the child). * Severe postpartum urinary retention requiring urinary catheterization. * Refusing to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score (Visual Analog Scale for Pain, VAS-P) | From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention) | Pain is assessed using Visual Analog Scale (VAS-P) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety score (Visual Analog Scale for Anxiety, VAS-A) | From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention) | Anxiety will be assessed using a 10cm Visual Analog Scale for Anxiety (VAS-A), where 0 indicates no anxiety and 10 indicates extreme anxiety. |
| Change in state anxiety score (State-Trait Anxiety Inventory - State scale, STAI-Y1) | From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention) | State anxiety will be measured using the 20-item STAI-Y1 questionnaire (scores range from 20 to 80, with higher scores indicating higher anxiety). |
| Incidence of adverse events related to the intervention | From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention) | All adverse events (e.g., pain at site, fatigue, bruising, internal bleeding, nerve injury) will be recorded throughout the study period. |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORDieu Huong Truong
University of Medicine and Pharmacy at Ho Chi Minh City
Outcome results
None listed