NCT07411417

Brief Summary

Pain is a subjective, sensory and emotionally unpleasant experience resulting from real or hidden injuries in tissues. The pain experience is a subjective and unique experience in physiological and psychological terms and is the first negative sensory experience of the patient after the surgical procedure. Thoracotomy is an invasive surgical incision that causes severe postoperative pain due to the negative effect on the ribs, muscles and peripheral nerves. During thoracic surgery, anatomical lung resection is performed through posterolateral thoracotomy. Surgical incision during thoracotomy surgery is the most severe cause of postoperative pain. Epidural analgesia, peripheral nerve block and systematic treatment methods are used in post-thoracotomy pain management. Opioid use is frequently preferred in post-thoracotomy pain management. Although thoracotomy pain can mostly be controlled with opioid analgesics, excessive use of opioids may lead to respiratory suppression, constipation, suppression of cough, nausea, vomiting and many other possible side effects. Ineffective postoperative pain management may lead to postoperative complications such as increased cardiac workload, prolonged pulmonary rehabilitation and delayed wound healing. The use of holistic non-drug pain relief methods is vital in reducing the need for opioid analgesics and the risk of possible side effects in early postoperative pain management.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2025

Typical duration for not_applicable

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 Progress67%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 6, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

March 31, 2025

Last Update Submit

February 11, 2026

Conditions

Keywords

Thoracotomy after PainAcupressurePainLung Volume

Outcome Measures

Primary Outcomes (1)

  • Pain after thoracotomy

    Pain after thoracotomy

    The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery,

Secondary Outcomes (1)

  • Pain during rest

    The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery

Other Outcomes (5)

  • Pain during respiratory exercise

    The patient's visual analogue scale pain score (VAS) at 2, 6, and 24 hours post-surgery

  • Pain during coughing exercise

    The patient's visual analogue scale pain score at (VAS) 2, 6, and 24 hours post-surgery

  • Lung function

    Preoperative triflow measurement results and postoperative 24-hour triflow measurement results (cc/s)

  • +2 more other outcomes

Study Arms (2)

Acupressure group

EXPERIMENTAL

Patients meeting the research criteria were included in the experimental group according to the randomisation table. The acupressure combination will be applied to the LI11, LU7, LU9, LU5, LU1, LU2, TE5, TE6,PC4, PC6 and LI4 points 2, 6 and 24 hours after surgery. Applications will last 1 minute for each point. Applications will last 1 minute for each point. Patients in this group will continue to receive routine clinical treatment and care. The patients' pain level during rest, breathing, coughing and mobilisation before surgery and 2, 6 and 24 hours after surgery, blood pressure, respiratory rate, respiratory count, SpO2 values, and lung volume before surgery and 24 hours after surgery will be measured and recorded using triflow. Additionally, the individuals' breathing and coughing exercise status will be assessed within the first 24 hours after surgery. These stages will also be carried out in a similar manner in the control group without any intervention.

Other: Acupressure group

Control group

NO INTERVENTION

Patients meeting the study criteria were included in the control group according to the randomisation table. Patients in this group will continue to receive routine clinical treatment and care. The patients' pain level during rest, breathing, coughing and mobilisation before surgery and 2, 6 and 24 hours after surgery, blood pressure, respiratory rate, respiratory count, SpO2 values, and lung volume before surgery and 24 hours after surgery will be measured and recorded using triflow. Additionally, individuals' breathing and coughing exercise status will be assessed within the first 24 hours after surgery.

Interventions

A series of acupressure applications

Acupressure group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Underwent thoracotomy
  • Undergoing thoracic surgery for the first time
  • Classified as ASA (American Society of Anesthesiology) physical status I, II and III
  • Presence of a drain upon admission to the intensive care unit
  • Conscious, oriented, and cooperative
  • Provided verbal and written informed consent after receiving information about the study

You may not qualify if:

  • Intubated
  • Persistent anxiety before the surgery
  • Diagnosed with panic disorder
  • Chemotherapy within the last 6 months
  • Diagnosed psychiatric illness or mental health problems
  • Presence of edema
  • Intraoperative or postoperative complications
  • Non-Turkish speaking, or presence of hearing or visual impairment
  • Body mass index (BMI) greater than 30
  • Participation in another clinical trial during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özgül Aydemir

Istanbul, 34067, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute PainMouth BreathingCoughPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Officials

  • İlhan Öztekin, Professör

    Yeditepe University

    STUDY DIRECTOR
  • Seher Deniz Öztekin, Professör

    Doğuş University

    STUDY DIRECTOR

Central Study Contacts

Özgül Aydemir, Doctor

CONTACT

Öykü Kara, Specialist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomised controlled experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 31, 2025

First Posted

February 13, 2026

Study Start

January 6, 2025

Primary Completion (Estimated)

June 6, 2026

Study Completion (Estimated)

January 6, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations