NCT07301073

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 28, 2025

Last Update Submit

December 10, 2025

Conditions

Keywords

Progressive RelaxationEmergency SurgeryPostoperative PainAnxietyPhysiological Parameters

Outcome Measures

Primary Outcomes (2)

  • Change in Postoperative Pain Score (SF-MPQ Total Score)

    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)

    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 Outcomes (8)

  • Change in Trait Anxiety Score (STAI-Trait, TX-L2)

    Postoperative hour 6 and postoperative day 2.

  • Change in Systolic Blood Pressure

    Postoperative hour 6, postoperative day 1, postoperative day 2.

  • Change in Diastolic Blood Pressure

    Postoperative hour 6, postoperative day 1, and postoperative day 2.

  • Change in Heart Rate

    Postoperative hour 6, postoperative day 1, and postoperative day 2.

  • Change in Respiratory Rate

    Postoperative hour 6, postoperative day 1, and postoperative day 2.

  • +3 more secondary outcomes

Study Arms (2)

Progressive Relaxation Exercises (PRE) Intervention

EXPERIMENTAL

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)

Routine Postoperative Care Only

NO INTERVENTION

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.

Interventions

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

Progressive Relaxation Exercises (PRE) Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı Training and Research Hospital

Ağrı, Merkez, 04100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 34785078BACKGROUND
  • 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.

    PMID: 40993691BACKGROUND
  • 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.

    PMID: 32220520BACKGROUND
  • 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.

    PMID: 31555379BACKGROUND
  • Aslan, F. E. (2006). Ağrı değerlendirilmesi ve ölçümü. In F. E. Aslan (Ed.), Ağrı: Doğası ve Kontrolü (pp. 68-99). İstanbul Tıp Kitabevleri

    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

    BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAnxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • VOLKAN GÖKMEN, Doctorate

    Agri ibrahim Cecen Univercity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 24, 2025

Study Start

May 1, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations