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Postoperative Progressive Relaxation Exercises for Pain and Anxiety After Emergency Surgery

NCT ID: NCT07301073

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Emergency Surgical Procedures Postoperative Pain Postoperative Anxiety

Keywords

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Progressive Relaxation Emergency Surgery Postoperative Pain Anxiety Physiological Parameters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study used simple computer-generated randomization to allocate participants in a 1:1 ratio to the intervention or control arm. Participants remained in their assigned arm throughout the study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Outcome assessors who collected pain, anxiety, and physiological measurements were masked to group assignment throughout the study. Data analysts were also blinded by using coded datasets without group identifiers. Participants and care providers could not be masked due to the behavioral nature of the intervention, but standard postoperative care protocols were applied equally to minimize performance bias.

Study Groups

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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.

Group Type EXPERIMENTAL

Progressive Relaxation Exercises (PRE)

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agri Ibrahim Cecen University

OTHER

Sponsor Role lead

Responsible Party

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Volkan Gokmen

Asisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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VOLKAN GÖKMEN, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Agri ibrahim Cecen Univercity

Locations

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Ağrı Training and Research Hospital

Ağrı, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 34785078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40993691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32220520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31555379 (View on PubMed)

Aslan, F. E. (2006). Ağrı değerlendirilmesi ve ölçümü. In F. E. Aslan (Ed.), Ağrı: Doğası ve Kontrolü (pp. 68-99). İstanbul Tıp Kitabevleri

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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PRE-EMERGENCY-2021

Identifier Type: -

Identifier Source: org_study_id