NCT07787871

Brief Summary

This randomized, sham-controlled clinical trial aims to evaluate the effect of acupressure on postoperative pain following laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. A total of 90 participants will be randomly assigned to one of three groups: standard postoperative care alone (control group), true acupressure plus standard care, or sham acupressure plus standard care. Acupressure will be applied at postoperative hours 1, 4, and 8 using the bilateral P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao) acupoints. The sham group will receive pressure at non-acupuncture points. The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include analgesic consumption, postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Jun 2026Oct 2026

Study Start

First participant enrolled

June 20, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 23, 2026

Last Update Submit

August 23, 2026

Conditions

Keywords

AcupressureSham AcupressureTEPLaparoscopic Totally Extraperitoneal Hernia RepairInguinal HerniaPostoperative PainRandomized Controlled TrialVisual Analog ScaleComplementary Medicine

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity Assessed by Visual Analog Scale

    Postoperative pain intensity will be assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be recorded at postoperative hours 2, 4, 6, 12, and 24 and compared among the study groups.

    At postoperative hours 2, 4, 6, 12, and 24

Secondary Outcomes (4)

  • Rescue Analgesic Requirement

    During the first 24 postoperative hours

  • Incidence of Postoperative Nausea and Vomiting

    During the first 24 postoperative hours

  • Early Postoperative Complications

    During the first 24 postoperative hours

  • Rescue Antiemetic Requirement

    During the first 24 postoperative hours

Study Arms (3)

Control

NO INTERVENTION

Participants receive standard postoperative care without acupressure.

Acupressure

EXPERIMENTAL

Participants receive standard postoperative care plus true acupressure at bilateral P6, LI4, ST36, and SP6 points for 3 minutes per point at postoperative 1, 4, and 8 hours.

Procedure: Acupressure

Sham Acupressure

SHAM COMPARATOR

Participants receive standard postoperative care plus sham acupressure at non-acupoint locations with the same duration and schedule as the acupressure group.

Procedure: Sham Acupressure

Interventions

AcupressurePROCEDURE

Bilateral acupressure is applied at P6, LI4, ST36, and SP6 for 3 minutes per point at postoperative 1, 4, and 8 hours.

Acupressure

Manual pressure is applied to non-acupuncture points using the same duration and schedule as the active acupressure intervention.

Sham Acupressure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75 years
  • Diagnosis of a unilateral primary inguinal hernia
  • Scheduled to undergo elective laparoscopic total extraperitoneal (TEP) inguinal hernia repair
  • American Society of Anesthesiologists (ASA) physical status I to III without an anticipated need for postoperative intensive care
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Bilateral inguinal hernia
  • Recurrent inguinal hernia
  • Strangulated inguinal hernia
  • History of open lower abdominal surgery
  • Skin infection, wound, or surgical scar at any of the acupressure application sites
  • ASA physical status III with an anticipated need for postoperative intensive care
  • ASA physical status IV
  • Participation in another clinical study within the previous 4 weeks
  • Receipt of acupressure or a similar complementary treatment within the previous 4 weeks
  • Refusal or inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeHernia, Inguinal

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHernia, AbdominalHerniaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to treatment allocation. The practitioner delivering the intervention cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups: control, acupressure, or sham acupressure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 26, 2026

Study Start

June 20, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data will not be made publicly available due to participant confidentiality and institutional data protection requirements. Aggregate study results will be reported in scientific publications.

Locations