Emergency Surgical ProceduresPRE-ESNCT07301073
Postoperative Progressive Relaxation Exercises for Pain and Anxiety After Emergency Surgery
A study testing Progressive Relaxation Exercises (PRE) in people with Emergency Surgical Procedures and Postoperative Pain, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Surgical Procedures, Postoperative Pain, Postoperative Anxiety
- What is being tested?
- Progressive Relaxation Exercises (PRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Training and Research Hospital
Ağrı, Merkez, 04100
About this study
Official title: The Effect of Postoperative Progressive Relaxation Exercises on Pain, Anxiety, and Physiological Parameters in Emergency General Surgery Patients: A Randomized Controlled Clinical Trial
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.
Read the 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.
- Being tested
- Progressive Relaxation Exercises (PRE)
- Keywords
- Progressive Relaxation, Emergency Surgery, Postoperative Pain, Anxiety, Physiological Parameters
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation Exercises (PRE)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative hour 6 and postoperative day 2.
Secondary outcomes (8)
Change in Trait Anxiety Score (STAI-Trait, TX-L2)
Trait anxiety will be assessed using the STAI-Trait Inventory. Score Range: 20 to 80. Higher scores indicate greater trait anxiety.
Measured: Postoperative hour 6 and postoperative day 2.
Change in Systolic Blood Pressure
Systolic blood pressure will be measured using a calibrated sphygmomanometer after 10 minutes of rest. Higher values indicate higher systolic blood pressure.
Measured: Postoperative hour 6, postoperative day 1, postoperative day 2.
Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured using a calibrated sphygmomanometer after 10 minutes of rest.
Measured: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Heart Rate
Heart rate will be measured using bedside monitoring after 10 minutes of rest.
Measured: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Respiratory Rate
Respiratory rate will be measured using standard clinical monitoring after 10 minutes of rest.
Measured: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Oxygen Saturation (SpO₂)
Peripheral oxygen saturation will be measured using pulse oximetry. Higher values indicate better oxygenation.
Measured: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
NSAID use will be recorded at each postoperative assessment based on medication administration records. Higher values indicate greater NSAID consumption.
Measured: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Use of Opioid Analgesics
Opioid analgesic use will be recorded at each postoperative assessment based on medication administration records. Higher values indicate greater opioid consumption.
Measured: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 May 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emergency Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Gokmen, Agri Ibrahim Cecen University
- Investigators
- VOLKAN GÖKMEN, Doctorate, Principal investigator, Agri ibrahim Cecen Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301073
- Sponsor's protocol ID
- PRE-EMERGENCY-2021
- Acronym
- PRE-ES
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34785078Akinci 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.
PubMed 40993691Kisaarslan 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.
PubMed 32220520Ju 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.
PubMed 31555379Aslan, 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 at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Progressive Relaxation Exercises on Pain, Anxiety, and Physiological Parameters in Emergency General Surgery Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07301073
- Acronym / sponsor ID
- PRE-ES / PRE-EMERGENCY-2021
- Keywords
- Progressive Relaxation, Emergency Surgery, Postoperative Pain, Anxiety, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation Exercises (PRE) Intervention | Experimental | Behavioral: Progressive Relaxation Exercises (PRE)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Progressive Relaxation Exercises (PRE) Intervention |
Primary outcome
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.
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.
8 secondary outcomes
Change in Trait Anxiety Score (STAI-Trait, TX-L2)
Time frame: Postoperative hour 6 and postoperative day 2.
Change in Systolic Blood Pressure
Time frame: Postoperative hour 6, postoperative day 1, postoperative day 2.
Change in Diastolic Blood Pressure
Time frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Heart Rate
Time frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Respiratory Rate
Time frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Change in Oxygen Saturation (SpO₂)
Time frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Time frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Use of Opioid Analgesics
Time frame: Postoperative hour 6, postoperative day 1, and postoperative day 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 34785078Loh 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.
- Background: PubMed 40993691Akinci 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.
- Background: PubMed 32220520Kisaarslan 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.
- Background: PubMed 31555379Ju 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.
- BackgroundAslan, F. E. (2006). Ağrı değerlendirilmesi ve ölçümü. In F. E. Aslan (Ed.), Ağrı: Doğası ve Kontrolü (pp. 68-99). İstanbul Tıp Kitabevleri
- BackgroundAbbasi, 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
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VOLKAN GÖKMEN, Doctorate principal investigator
Agri ibrahim Cecen Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises (PRE) in people with Emergency Surgical Procedures and Postoperative Pain, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Pain Score (SF-MPQ Total Score) (time frame: Postoperative hour 6 and postoperative day 2.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07301073, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.