Ağrı Training and Research Hospital
Ağrı, Merkez, 04100, Turkey (Türkiye)
NCT Number: NCT07301073
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Ağrı, Merkez, 04100, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Agri Ibrahim Cecen University
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07039812
Agnosia, Anxiety Disorders
Istanbul, Marmara, Turkey (Türkiye)
View Trial DetailsNCT07644065
Anxiety, Anxiety Disorders
Plovdiv, Bulgaria
View Trial DetailsNCT05986942
Anxiety, Anxiety Disorders
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07433296
Anxiety Disorders, Mental Disorders
Samsun, Turkey (Türkiye)
View Trial Details