NCT07805720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

15 days

First QC Date

September 1, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

AcupressureCesarean SectionAnxietyPostoperative PainLI4PC6SP6

Outcome Measures

Primary Outcomes (1)

  • Change in pain score (Visual Analog Scale for Pain, VAS-P)

    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.

    From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention)

Secondary Outcomes (3)

  • Change in anxiety score (Visual Analog Scale for Anxiety, VAS-A)

    From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention)

  • Change in state anxiety score (State-Trait Anxiety Inventory - State scale, STAI-Y1)

    From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention)

  • Incidence of adverse events related to the intervention

    From baseline (T1, pre-intervention) to Day 3 (T2, post-intervention)

Study Arms (2)

Real Acupressure + Standard Care

EXPERIMENTAL

Participants receive real acupressure at Hegu (LI4), Neiguan (PC6), and Sanyinjiao (SP6) points for 15 minutes daily over 3 consecutive days post-cesarean section, combined with standard modern medical care.

Procedure: AcupressureBehavioral: Standard care

Sham Acupressure + standard care

SHAM COMPARATOR

Participants receive sham acupressure at non-acupoints for 15 minutes daily over 3 consecutive days post-cesarean section, combined with standard modern medical care.

Procedure: Sham AcupressureBehavioral: Standard care

Interventions

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.

Sham Acupressure + standard care
AcupressurePROCEDURE

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.

Real Acupressure + Standard Care
Standard careBEHAVIORAL

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.

Real Acupressure + Standard Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tien Giang Obstetrics and Gynecology Hospital

Mỹ Tho, Tien Giang, Vietnam

Location

MeSH Terms

Conditions

Pain, PostoperativeAnxiety Disorders

Interventions

AcupressureStandard of Care

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Dieu Huong Truong

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

April 25, 2026

Primary Completion

May 10, 2026

Study Completion

May 10, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations