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Clinical Trials/NCT07175558
NCT07175558CompletedNot Applicable

Effects of Reiki Applied to Patients Undergoing Colorectal Cancer Surgery on Postoperative Pain, Anxiety, Physiological Parameters and Recovery

Istanbul University - Cerrahpasa1 site in 1 country64 target enrollmentStarted: July 10, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
64
Locations
1
Primary Endpoint
Pain NRS Scale: Time 1

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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,
  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istanbul University - Cerrahpasa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sena Melike Tasci

Principal Investigator

Istanbul University - Cerrahpasa

Study Sites (1)

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