- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07301073
Postoperative Progressive Relaxation Exercises for Pain and Anxiety After Emergency Surgery (PRE-ES)
The Effect of Postoperative Progressive Relaxation Exercises on Pain, Anxiety, and Physiological Parameters in Emergency General Surgery Patients: A Randomized Controlled Clinical Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Merkez
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Ağrı, Merkez, Turkey (Türkiye), 04100
- Ağrı Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
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
|
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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.
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Change in Systolic Blood Pressure
Time Frame: Postoperative hour 6, postoperative day 1, postoperative day 2.
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Systolic blood pressure will be measured using a calibrated sphygmomanometer after 10 minutes of rest.
Higher values indicate higher systolic blood pressure.
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Postoperative hour 6, postoperative day 1, postoperative day 2.
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Change in Diastolic Blood Pressure
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Diastolic blood pressure will be measured using a calibrated sphygmomanometer after 10 minutes of rest.
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Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Change in Heart Rate
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Heart rate will be measured using bedside monitoring after 10 minutes of rest.
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Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Change in Respiratory Rate
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Respiratory rate will be measured using standard clinical monitoring after 10 minutes of rest.
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Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Change in Oxygen Saturation (SpO₂)
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Peripheral oxygen saturation will be measured using pulse oximetry.
Higher values indicate better oxygenation.
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Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
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NSAID use will be recorded at each postoperative assessment based on medication administration records.
Higher values indicate greater NSAID consumption.
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Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Use of Opioid Analgesics
Time Frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Opioid analgesic use will be recorded at each postoperative assessment based on medication administration records.
Higher values indicate greater opioid consumption.
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Postoperative hour 6, postoperative day 1, and postoperative day 2.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Volkan GOKMEN, Doctorate, Agri ibrahim Cecen Univercity
Publications and helpful links
General Publications
- Ju W, Ren L, Chen J, Du Y. Efficacy of relaxation therapy as an effective nursing intervention for post-operative pain relief in patients undergoing abdominal surgery: A systematic review and meta-analysis. Exp Ther Med. 2019 Oct;18(4):2909-2916. doi: 10.3892/etm.2019.7915. Epub 2019 Aug 19.
- Loh EW, Shih HF, Lin CK, Huang TW. Effect of progressive muscle relaxation on postoperative pain, fatigue, and vital signs in patients with head and neck cancers: A randomized controlled trial. Patient Educ Couns. 2022 Jul;105(7):2151-2157. doi: 10.1016/j.pec.2021.10.034. Epub 2021 Nov 3.
- Akinci N. Effect of progressive muscle relaxation on postoperative pain in laparoscopic living kidney donors: a randomized controlled trial. BMC Surg. 2025 Sep 24;25(1):410. doi: 10.1186/s12893-025-03187-y.
- Kisaarslan M, Aksoy N. Effect of Progressive Muscle Relaxation Exercise on Postoperative Pain Level in Patients Undergoing Open Renal Surgery: A Nonrandomized Evaluation. J Perianesth Nurs. 2020 Aug;35(4):389-396. doi: 10.1016/j.jopan.2019.12.003. Epub 2020 Mar 24.
- Aslan, F. E. (2006). Ağrı değerlendirilmesi ve ölçümü. In F. E. Aslan (Ed.), Ağrı: Doğası ve Kontrolü (pp. 68-99). İstanbul Tıp Kitabevleri
- Abbasi, A., Naderi, Z., & Zakerimoghadam, M. (2018). The effect of progressive muscle relaxation on postoperative pain and physiological parameters in patients undergoing abdominal surgery. Journal of PeriAnesthesia Nursing, 33(5), 512-520. https://doi.org/10.1016/j.jopan.2017.11.010
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRE-EMERGENCY-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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