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Completed

NCT Number: NCT07301073

Postoperative Progressive Relaxation Exercises for Pain and Anxiety After Emergency Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ağrı Training and Research Hospital

Ağrı, Merkez, 04100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Progressive Relaxation Exercises (PRE)

Behavioral

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

Primary outcomes

  1. 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.

  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.

Secondary outcomes

  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Agri Ibrahim Cecen University

Other

Registry information

Official study title

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

Acronym: PRE-ES

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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