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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Progressive Relaxation Exercises (PRE)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agri Ibrahim Cecen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRE-EMERGENCY-2021

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.

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