Colorectal CancerNCT07175558
Effects of Reiki Applied to Patients Undergoing Colorectal Cancer Surgery on Postoperative Pain, Anxiety, Physiological Parameters and Recovery
A study testing Reiki in people with Colorectal Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Reiki touch therapy has been used for many years, especially on pain, anxiety and physiological parameters, and studies have been found to show that it is effective. In a systematic review conducted with Sectio patients, it was determined that reiki reduces pain. In a study conducted by Zare et al. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 30 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who volunteer to participate and continue in the study,
- Have no communication problems that would prevent the interview,
- Have pain levels of 5 and above according to the GKO,
- Have no history of psychiatric disorders and therefore do not use medication will be included in the study.
Who cannot join
- If a different surgical procedure is performed other than colorectal surgery,
- If the score determined in the Visual Comparison Scale in the pre-operative evaluation of the patient is 7 and above,
- If there is cancer pain,
- If there are complex cancer metastases,
- If there are secondary metastases from colorectal cancer,
- If there is persistent severe nausea and vomiting during the procedure and post-operative period,
Show all 11Show fewer
- If the patient is illiterate,
- If the patient is over 50 points from the Trait Anxiety Scale,
- If the patient has had abdominal surgery before,
- If the patient has had reiki or energy therapies before,
- If the patient is using medications other than the routine treatment after the surgery, the patients will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Eğitim ve Araştırma Hastanesi
Istanbul, Istanbul, 34440
About this study
Reiki touch therapy has been used for many years, especially on pain, anxiety and physiological parameters, and studies have been found to show that it is effective. In a systematic review conducted with Sectio patients, it was determined that reiki reduces pain. In a study conducted by Zare et al. with patients undergoing coronary bypass surgery, it was reported that reiki regulates the respiratory rate. It was determined that reiki applied to the incision area in patients undergoing abdominal surgery reduces pain. In a different study, it was emphasized that reiki applied to 90 women who gave birth by cesarean section in the experimental group on the 1st and 2nd days after surgery decreased pain and anxiety levels, analgesic requirement and respiratory rate after surgery compared to the control group, while there was no change in blood pressure and pulse. In a meta-analysis study including four studies consisting of 104 patients in the Reiki group and 108 patients in the control group, a statistically significant decrease in the pain score of the Reiki group was found. In a study conducted by Bremner and colleagues, it was determined that stress, anxiety and depression decreased in the Reiki group. In a study measuring the effect of Reiki use on pain, stress and anxiety levels in patients undergoing total knee replacement surgery, significant decreases were found in pain, blood pressure, respiratory rate and anxiety levels in the Reiki group out of three groups that received Reiki, sham Reiki and standard care. In line with these studies, evidence-based data on the effectiveness of Reiki is thought to help nurses reduce patients' postoperative pain and anxiety, reduce the incidence of respiratory complications and help them evaluate and manage physiological parameters more accurately.
- Conditions
- Colorectal Cancer
- Being tested
- Reiki
- Keywords
- Reiki, Nursing care, Surgical Nursing, Colorectal Cancer Surgery, Physiological Parameters
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
The patient will be explained about reiki (life energy recovery) and the application environment will be kept quiet.
Metal objects on the patient and the researcher will be removed. The researcher will wash and warm their hands. The patient's privacy will be ensured. The patient will be given a flat lying position with their arms and legs on both sides and comfortable. The patient will be asked to close their eyes. The researcher's fingers will be straight, side by side and closed, and energy will be provided to the application areas; crown chakra (top of the head), forehead chakra (top of the forehead), throat chakra (top of the throat), heart chakra (middle of the chest), solar plexus (under the chest, above the navel), sacral chakra (below the navel) and root chakra (upper back). Reiki application will be applied to the points on the 7 chakra regions for 4 minutes each, for a total of 28 minutes. The patient will be asked to open their eyes at the end of the application.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Group | Experimental | The patient will be explained about reiki (life energy recovery) and the application environment will be kept quiet. Metal objects on the patient and the researcher will be removed. The researcher will wash and warm their hands. The patient's privacy will be ensured. The patient will be given a flat lying position with their arms and legs on both sides and comfortable. The patient will be asked to close their eyes. The researcher's fingers will be straight, side by side and closed, and energy will be provided to the application areas; crown chakra (top of the head), forehead chakra (top of the forehead), throat chakra (top of the throat), heart chakra (middle of the chest), solar plexus (under the chest, above the navel), sacral chakra (below the navel) and root chakra (upper back). Reiki application will be applied to the points on the 7 chakra regions for 4 minutes each, for a total of 28 minutes. The patient will be asked to open their eyes at the end of the application. Receives: Other: Reiki |
| Control Group | No intervention | The control group will not receive any intervention and will receive care in accordance with the clinic's own schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain NRS Scale: Time 1
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: Before surgery
Pain NRS Scale: Time 2
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: 4th hour after surgery
Pain NRS Scale: Time 3
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: 1st day after surgery
Pain NRS Scale: Time 4
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: 2nd day after surgery
State-Trait Anxiety Inventory: Time 1
Developed by Spielberger, Gorsuch, and Lushene in 1970, the scale consists of two subscales with 20 items each measuring state and trait anxiety. The STAI used in this study is answered using a 4-point Likert scale. The emotions and behaviors expressed in the STAI items are indicated by selecting one of the following options: (1) Not at all, (2) A little, (3) A lot, and (4) Completely, according to the severity of such experiences. High scores on the scale indicate high levels of anxiety The highest score is 80, and the lowest is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted. . The adaptation, validity, and reliability study of the scale was conducted into Turkish by Öner and Le Compte in 1983. Cronbach's α internal consistency rate for the scale's current sample was found to be 0.90 for the State Anxiety Scale.
Measured: Before surgery
State-Trait Anxiety Inventory: Time 2
Developed by Spielberger, Gorsuch, and Lushene in 1970, the scale consists of two subscales with 20 items each measuring state and trait anxiety. The STAI used in this study is answered using a 4-point Likert scale. The emotions and behaviors expressed in the STAI items are indicated by selecting one of the following options: (1) Not at all, (2) A little, (3) A lot, and (4) Completely, according to the severity of such experiences. High scores on the scale indicate high levels of anxiety The highest score is 80, and the lowest is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted. The adaptation, validity, and reliability study of the scale was conducted into Turkish by Öner and Le Compte in 1983. Cronbach's α internal consistency rate for the scale's current sample was found to be 0.90 for the State Anxiety Scale.
Measured: 2nd day after surgery
Postoperative Recovery Index
The postoperative recovery index, the validity and reliability of which was conducted by Butler et al. (2012), consists of 25 items. The ASII has five subdimensions: psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire symptoms. In scoring the questionnaire, the scores of the items in the subdimensions are summed, their arithmetic means are taken, and the subdimension score is determined. To obtain the total score of the ASII survey, all 25 items are summed and their arithmetic mean is taken. High scores on the index reflect more difficulties in postoperative recovery, while low scores indicate that postoperative recovery was easier. In this study, the ASII, the validity and reliability of which was conducted for Turkish by Hande Cengiz in 2018, was used.
Measured: 15th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start10 Jul 2023
- Primary completion26 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- a randomized controlled trial with an intervention and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Melike Tasci, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175558
- Sponsor's protocol ID
- RPAPR
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the study can be shared after completion if requested by the reader.
Publications
1. Thrane, S, Cohen, SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain management nursing, 2014,15(4), 897-908. 2. Zare, Z. Shahsavari, H, Moeini, M. Effects of therapeutic touch on the vital signs of patients before coronary artery bypass graft surgery. Iranian Journal of Nursing and Midwifery Research. 2010;15(1), 37-42. 3. 3. Sagkal Midilli, T. Ciray Gunduzoglu, N. Effects of reiki on pain and vital signs when applied to the ıncision area of the body after cesarean section surgery: A single-blinded, randomized, double-controlled study. Holistic Nursing Practice. 2016;30(6), 368-378. 4. Demirdogan M. The effect of Reiki on pain: A meta-analysis. Complementary Therapies in Clinical Practice. 2018;31, 384-387 5. Baldwin AL, Vitale A, Brownell E, Kryak E, Rand W. Effects of reiki on pain, anxiety, and blood pressure in patients undergoing kneere placement. Holistic Nursing Practice. 2017;31(2): 80-89. 6. Keşer, E, Bağlama, SS, Sezer, C. The effect of reiki and aromatherapy on vital signs, oxygen saturation, and anxiety level in patients undergoing upper gastrointestinal endoscopy: A randomized controlled study. Holistic Nursing Practice, 2023;37(6):337-346. 7. Şişman, H, Arslan, S. The effect of reiki on anxiety, fear, pain, and oxygen saturation in abdominal surgery patients: A randomized controlled trial. Explore. 2023;19(4), 578-586. 8. Yeşil Bayülgen, M, Gün, M. The effect of Reiki on fatigue and comfort in hemodialysis patients. Explore. 2023;19(4):553-560.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reiki Applied to Patients Undergoing Colorectal Cancer Surgery on Postoperative Pain, Anxiety, Physiological Parameters and Recovery
- ClinicalTrials.gov ID
- NCT07175558
- Acronym / sponsor ID
- RPAPR
- Conditions
- Colorectal Cancer
- Keywords
- Reiki, Nursing care, Surgical Nursing, Colorectal Cancer Surgery, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 16 Sep 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.
Reiki touch therapy has been used for many years, especially on pain, anxiety and physiological parameters, and studies have been found to show that it is effective. In a systematic review conducted with Sectio patients, it was determined that reiki reduces pain. In a study conducted by Zare et al. with patients undergoing coronary bypass surgery, it was reported that reiki regulates the respiratory rate. It was determined that reiki applied to the incision area in patients undergoing abdominal surgery reduces pain. In a different study, it was emphasized that reiki applied to 90 women who gave birth by cesarean section in the experimental group on the 1st and 2nd days after surgery decreased pain and anxiety levels, analgesic requirement and respiratory rate after surgery compared to the control group, while there was no change in blood pressure and pulse. In a meta-analysis study including four studies consisting of 104 patients in the Reiki group and 108 patients in the control group, a statistically significant decrease in the pain score of the Reiki group was found. In a study conducted by Bremner and colleagues, it was determined that stress, anxiety and depression decreased in the Reiki group. In a study measuring the effect of Reiki use on pain, stress and anxiety levels in patients undergoing total knee replacement surgery, significant decreases were found in pain, blood pressure, respiratory rate and anxiety levels in the Reiki group out of three groups that received Reiki, sham Reiki and standard care. In line with these studies, evidence-based data on the effectiveness of Reiki is thought to help nurses reduce patients' postoperative pain and anxiety, reduce the incidence of respiratory complications and help them evaluate and manage physiological parameters more accurately.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized controlled trial with an intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Reiki Group | Experimental | Other: ReikiThe patient will be explained about reiki (life energy recovery) and the application environment will be kept quiet. Metal objects on the patient and the researcher will be removed. The researcher will wash and warm their hands. The patient's privacy will be ensured. The patient will be given a flat lying position with their arms and legs on both sides and comfortable. The patient will be asked to close their eyes. The researcher's fingers will be straight, side by side and closed, and energy will be provided to the application areas; crown chakra (top of the head), forehead chakra (top of the forehead), throat chakra (top of the throat), heart chakra (middle of the chest), solar plexus (under the chest, above the navel), sacral chakra (below the navel) and root chakra (upper back). Reiki application will be applied to the points on the 7 chakra regions for 4 minutes each, for a total of 28 minutes. The patient will be asked to open their eyes at the end of the application. |
| Control Group | No intervention | –The control group will not receive any intervention and will receive care in accordance with the clinic's own schedule. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who volunteer to participate and continue in the study,
- Have no communication problems that would prevent the interview,
- Have pain levels of 5 and above according to the GKO,
- Have no history of psychiatric disorders and therefore do not use medication will be included in the study.
Key exclusion criteria (11 listed)
- If a different surgical procedure is performed other than colorectal surgery,
- If the score determined in the Visual Comparison Scale in the pre-operative evaluation of the patient is 7 and above,
- If there is cancer pain,
- If there are complex cancer metastases,
- If there are secondary metastases from colorectal cancer,
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 |
|---|---|---|
| ReikiThe patient will be explained about reiki (life energy recovery) and the application environment will be kept quiet. Metal objects on the patient and the researcher will be removed. The researcher will wash and warm their hands. The patient's privacy will be ensured. The patient will be given a flat lying position with their arms and legs on both sides and comfortable. The patient will be asked to close their eyes. The researcher's fingers will be straight, side by side and closed, and energy will be provided to the application areas; crown chakra (top of the head), forehead chakra (top of the forehead), throat chakra (top of the throat), heart chakra (middle of the chest), solar plexus (under the chest, above the navel), sacral chakra (below the navel) and root chakra (upper back). Reiki application will be applied to the points on the 7 chakra regions for 4 minutes each, for a total of 28 minutes. The patient will be asked to open their eyes at the end of the application. | Other | Reiki Group |
Primary outcome
Pain NRS Scale: Time 1
Time frame: Before surgery
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Pain NRS Scale: Time 2
Time frame: 4th hour after surgery
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Pain NRS Scale: Time 3
Time frame: 1st day after surgery
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Pain NRS Scale: Time 4
Time frame: 2nd day after surgery
The pain experienced should be numbered on a linear line and rated as "none, mild, moderate, or severe." A rating of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
State-Trait Anxiety Inventory: Time 1
Time frame: Before surgery
Developed by Spielberger, Gorsuch, and Lushene in 1970, the scale consists of two subscales with 20 items each measuring state and trait anxiety. The STAI used in this study is answered using a 4-point Likert scale. The emotions and behaviors expressed in the STAI items are indicated by selecting one of the following options: (1) Not at all, (2) A little, (3) A lot, and (4) Completely, according to the severity of such experiences. High scores on the scale indicate high levels of anxiety The highest score is 80, and the lowest is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted. . The adaptation, validity, and reliability study of the scale was conducted into Turkish by Öner and Le Compte in 1983. Cronbach's α internal consistency rate for the scale's current sample was found to be 0.90 for the State Anxiety Scale.
State-Trait Anxiety Inventory: Time 2
Time frame: 2nd day after surgery
Developed by Spielberger, Gorsuch, and Lushene in 1970, the scale consists of two subscales with 20 items each measuring state and trait anxiety. The STAI used in this study is answered using a 4-point Likert scale. The emotions and behaviors expressed in the STAI items are indicated by selecting one of the following options: (1) Not at all, (2) A little, (3) A lot, and (4) Completely, according to the severity of such experiences. High scores on the scale indicate high levels of anxiety The highest score is 80, and the lowest is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted. The adaptation, validity, and reliability study of the scale was conducted into Turkish by Öner and Le Compte in 1983. Cronbach's α internal consistency rate for the scale's current sample was found to be 0.90 for the State Anxiety Scale.
Postoperative Recovery Index
Time frame: 15th day after surgery
The postoperative recovery index, the validity and reliability of which was conducted by Butler et al. (2012), consists of 25 items. The ASII has five subdimensions: psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire symptoms. In scoring the questionnaire, the scores of the items in the subdimensions are summed, their arithmetic means are taken, and the subdimension score is determined. To obtain the total score of the ASII survey, all 25 items are summed and their arithmetic mean is taken. High scores on the index reflect more difficulties in postoperative recovery, while low scores indicate that postoperative recovery was easier. In this study, the ASII, the validity and reliability of which was conducted for Turkish by Hande Cengiz in 2018, was used.
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 16 Sep 2025.
- Background1. Thrane, S, Cohen, SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain management nursing, 2014,15(4), 897-908. 2. Zare, Z. Shahsavari, H, Moeini, M. Effects of therapeutic touch on the vital signs of patients before coronary artery bypass graft surgery. Iranian Journal of Nursing and Midwifery Research. 2010;15(1), 37-42. 3. 3. Sagkal Midilli, T. Ciray Gunduzoglu, N. Effects of reiki on pain and vital signs when applied to the ıncision area of the body after cesarean section surgery: A single-blinded, randomized, double-controlled study. Holistic Nursing Practice. 2016;30(6), 368-378. 4. Demirdogan M. The effect of Reiki on pain: A meta-analysis. Complementary Therapies in Clinical Practice. 2018;31, 384-387 5. Baldwin AL, Vitale A, Brownell E, Kryak E, Rand W. Effects of reiki on pain, anxiety, and blood pressure in patients undergoing kneere placement. Holistic Nursing Practice. 2017;31(2): 80-89. 6. Keşer, E, Bağlama, SS, Sezer, C. The effect of reiki and aromatherapy on vital signs, oxygen saturation, and anxiety level in patients undergoing upper gastrointestinal endoscopy: A randomized controlled study. Holistic Nursing Practice, 2023;37(6):337-346. 7. Şişman, H, Arslan, S. The effect of reiki on anxiety, fear, pain, and oxygen saturation in abdominal surgery patients: A randomized controlled trial. Explore. 2023;19(4), 578-586. 8. Yeşil Bayülgen, M, Gün, M. The effect of Reiki on fatigue and comfort in hemodialysis patients. Explore. 2023;19(4):553-560.
- Individual participant dataSharing planned: No. The data of the study can be shared after completion if requested by the reader.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki in people with Colorectal Cancer, run by Istanbul University - Cerrahpasa 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 4 inclusion and 11 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 16 Sep 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?
Pain NRS Scale: Time 1 (time frame: Before surgery). The study lists 7 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 NCT07175558, which also lists 1 linked publication.
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 16 Sep 2025.