Postoperative Progressive Relaxation Exercises for Pain and Anxiety After Emergency Surgery (PRE-ES)

December 10, 2025 updated by: Volkan Gokmen, Agri Ibrahim Cecen University

The Effect of Postoperative Progressive Relaxation Exercises on Pain, Anxiety, and Physiological Parameters in Emergency General Surgery Patients: A Randomized Controlled Clinical Trial

This randomized controlled trial investigated the effectiveness of postoperative progressive relaxation exercises (PRE) on pain, anxiety, and physiological parameters among adult patients undergoing emergency general surgery. Seventy patients were randomized to either a PRE intervention delivered at postoperative hour 6, postoperative day 1, and postoperative day 2, or to routine postoperative care. Pain (SF-MPQ), anxiety (STAI), and vital signs were measured. The trial demonstrated that PRE significantly reduced multidimensional pain and anxiety and improved heart rate, respiratory rate, and oxygen saturation. The study provides novel evidence that PRE is feasible and effective when implemented exclusively in the postoperative period among emergency surgical patients.

Study Overview

Detailed Description

This randomized, parallel-group clinical trial was conducted to evaluate the effectiveness and feasibility of postoperative progressive relaxation exercises (PRE) among patients undergoing emergency general surgery. Emergency surgical admissions provide no opportunity for preoperative preparation, and postoperative pain, anxiety, and autonomic instability are commonly intensified by acute physiological stress responses. The trial was designed to determine whether PRE, delivered exclusively after surgery, could reduce these symptoms and support early physiological recovery.

Following confirmation of postoperative stability at hour 6, eligible patients were randomly assigned in a 1:1 ratio to either the PRE intervention or routine postoperative care. The intervention consisted of standardized 30-minute sessions of progressive muscle relaxation conducted at postoperative hour 6, postoperative day 1, and postoperative day 2. Sessions followed a structured protocol including diaphragmatic breathing, sequential contraction-relaxation of major muscle groups, and a final integration phase. All sessions were delivered by a nurse trained in PRE.

Outcome assessments were conducted at prespecified time points using validated measures. Pain was evaluated with the Short-Form McGill Pain Questionnaire, anxiety with the State-Trait Anxiety Inventory, and physiological status through routine clinical monitoring of blood pressure, heart rate, respiratory rate, and oxygen saturation. Analyses examined both between-group differences and changes over time.

The study adhered to CONSORT guidelines for randomized trials and incorporated blinded outcome assessment and concealed allocation. No adverse events related to the intervention were reported, and all randomized participants completed follow-up.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Merkez
      • Ağrı, Merkez, Turkey (Türkiye), 04100
        • Ağrı Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults aged 18 years or older.
  2. Undergoing an emergency surgical procedure requiring postoperative hospitalization.
  3. Conscious, oriented, and hemodynamically stable by postoperative hour 6.
  4. Able to communicate and follow verbal instructions.
  5. No psychiatric, neurological, cognitive, or auditory impairment that would prevent participation.
  6. No chronic pain disorder and not using long-term opioids, sedatives, or anxiolytics before admission.
  7. Provided written informed consent.

Exclusion Criteria:

  1. Postoperative admission to the intensive care unit (ICU).
  2. Development of postoperative complications preventing participation (e.g., severe bleeding, respiratory distress, infection).
  3. Inability to complete all three scheduled PRE sessions.
  4. Postoperative confusion, delirium, or any condition limiting communication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive Relaxation Exercises (PRE) Intervention
Participants assigned to this arm received standardized Progressive Relaxation Exercises (PRE) consisting of three postoperative sessions (each 30 minutes in duration). Sessions were administered at postoperative hour 6, postoperative day 1, and postoperative day 2 by a nurse trained in PRE. The protocol included diaphragmatic breathing, sequential contraction-relaxation of major muscle groups, and a final integration phase. PRE was delivered in addition to routine postoperative care.
This intervention consists of structured Progressive Relaxation Exercises (PRE) delivered exclusively in the postoperative period. PRE involves diaphragmatic breathing, awareness of muscle tension, and sequential contraction-relaxation of major muscle groups (hands, arms, shoulders, neck, chest, abdomen, back, hips, legs, and feet). Each session lasts 30 minutes and is administered at the bedside by a nurse trained in PRE. The protocol includes a preparation phase (2-3 min), a muscle relaxation sequence (20-22 min), and an integration phase (3-5 min). PRE is delivered at postoperative hour 6, postoperative day 1, and postoperative day 2, in addition to routine care, and does not include any pharmacological components
No Intervention: Routine Postoperative Care Only
Participants in this arm received routine postoperative care according to institutional protocols, including physician-prescribed analgesics, vital sign monitoring, mobilization, wound care, and standard nursing follow-up. No relaxation-based or behavioral intervention was provided. Pain, anxiety, and physiological parameters were assessed at the same scheduled postoperative time points as in the intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Postoperative Pain Score (SF-MPQ Total Score)
Time Frame: Postoperative hour 6 and postoperative day 2.

Postoperative pain will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), which includes sensory and affective descriptors, the Present Pain Intensity (PPI) index, and a Visual Analogue Scale (VAS).

Total Score Range: 0 to 45. Higher scores indicate greater pain severity.

Postoperative hour 6 and postoperative day 2.
Change in State Anxiety Score (STAI-State, TX-L1)
Time Frame: Postoperative hour 6 and postoperative day 2.

SSituational anxiety will be assessed using the State Anxiety Inventory (STAI-State).

Score Range: 20 to 80. Higher scores indicate greater state anxiety.

Postoperative hour 6 and postoperative day 2.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Trait Anxiety Score (STAI-Trait, TX-L2)
Time Frame: Postoperative hour 6 and postoperative day 2.
Trait anxiety will be assessed using the STAI-Trait Inventory. Score Range: 20 to 80. Higher scores indicate greater trait anxiety.
Postoperative hour 6 and postoperative day 2.
Change in Systolic Blood Pressure
Time Frame: Postoperative hour 6, postoperative day 1, postoperative day 2.
Systolic blood pressure will be measured using a calibrated sphygmomanometer after 10 minutes of rest. Higher values indicate higher systolic blood pressure.
Postoperative hour 6, postoperative day 1, postoperative day 2.
Change in Diastolic Blood Pressure
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Diastolic blood pressure will be measured using a calibrated sphygmomanometer after 10 minutes of rest.
Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Heart Rate
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Heart rate will be measured using bedside monitoring after 10 minutes of rest.
Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Respiratory Rate
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Respiratory rate will be measured using standard clinical monitoring after 10 minutes of rest.
Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Oxygen Saturation (SpO₂)
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Peripheral oxygen saturation will be measured using pulse oximetry. Higher values indicate better oxygenation.
Postoperative hour 6, postoperative day 1, and postoperative day 2.
Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
NSAID use will be recorded at each postoperative assessment based on medication administration records. Higher values indicate greater NSAID consumption.
Postoperative hour 6, postoperative day 1, and postoperative day 2.
Use of Opioid Analgesics
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Opioid analgesic use will be recorded at each postoperative assessment based on medication administration records. Higher values indicate greater opioid consumption.
Postoperative hour 6, postoperative day 1, and postoperative day 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Volkan GOKMEN, Doctorate, Agri ibrahim Cecen Univercity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) from this study will not be shared because the dataset contains sensitive clinical information from emergency surgical patients, and full de-identification cannot be guaranteed without compromising data integrity. Additionally, institutional and national data protection policies restrict the sharing of raw patient-level data outside the hosting institution. Aggregated results and statistical summaries will be made available in publications, but no IPD files will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Progressive Relaxation Exercises (PRE)

Subscribe