Yoga-Based Breathing Exercise, Colorectal Cancer Surgery

NCT06446999 | Completed

• 1 other identifier: KaratayFG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as a prospective, parallel two groups and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery. The sample size of the study was conducted with 60 patients, 30 in the control group and 30 in the experimental group, according to the results of a similar study with the G\*Power 3.1., 9.7 program, with α = 0.05, 80% power and 0.648 effect, and taking into account possible losses. was planned. Research inclusion criteria; Patients who underwent colorectal cancer surgery for the first time were those who were 18 years of age or older, had a mobile phone suitable for downloading the yoga-based breathing exercise video, used the same type and dose of painkillers, and volunteered to participate in the study. "Personal Information Form", "VAS Pain Scale", "Brief Fatigue Inventory", "Richard Campbell Sleep Scale" and "Health Promotion Strategies Used by Patients Scale" will be used to collect data. Participants assigned to the experimental group will be provided with breathing exercises using a protocol containing Yoga-based breathing exercises. In order to conduct the research, approval will be obtained from KTO Karatay University Non-Drug and Medical Device Research Ethics Committee, ethics committee approval and permission will be obtained from the institution where the research will be conducted. Participation in the study is voluntary and written consent will be obtained from the participants. The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) statistical package program. A level of p\<0.05 will be considered statistically significant.

Conditions

Symptoms and Signs

Keywords

Colorectal cancer surgery; Yoga-Based Breathing Exercise; Pain; Fatigue; İnsomnia; Self Efficacy

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS) - Pain Scale

  A 10 cm ruler has been designed with painlessness on one side and the most severe pain possible on the other side. This ruler is known as the Visual Analog Scale (VAS) for visual comparison. In the evaluation of the scale, "0" indicates no pain, "1-3" indicates mild pain, "4-6" indicates moderate pain, and "7-10" indicates severe pain levels.

  One minute

• Brief Fatigue Inventory

  In the evaluation of fatigue, 0 points; no fatigue, 1-3 points; low fatigue, 4-6 points moderate fatigue, 7-9 points; extreme fatigue, 10 points; Fatigue is rated at the highest level.

  Two minutes

• Richard Campbell Sleep Scale

  It is a scale consisting of 6 items that assess the depth of nighttime sleep, the time it takes to fall asleep, the frequency of awakenings, the duration of wakefulness upon awakening, the quality of sleep, and the level of noise in the environment. Scores on the scale range from "0-25" indicating very poor sleep to "76-100" indicating very good sleep. While evaluating the total score of the scale based on 5 items, the 6th item, which assesses the level of noise in the environment, is excluded from the total score assessment. As the score on the scale increases, the quality of patients' sleep also increases.

  Two minutes

• A measure of self-care self-efficacy

  The minimum score obtained from the scale is 29 and the maximum score is 145. An increase in score indicates that the level of self-efficacy regarding self-care behaviors has increased.

  Two minutes

Study Arms (2)

Yoga-Based Breathing Exercise

EXPERIMENTAL

A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.

Other: Yoga-Based Breathing Exercise

Control

NO INTERVENTION

Continuity of routine treatment and care of the patients included in the control group will be ensured.

Interventions

Yoga-Based Breathing Exercise OTHER

Breathing Exercise Protocol Purpose: This protocol is a guide prepared for patients who agree to participate in the study within the scope of scientific research to do breathing exercises. Materials Required: A comfortable chair/a comfortable bed to lie on and comfortable clothing. Exercise Duration: Approximately 20 minutes Exercise Time and Frequency: It should be done twice a day, at the same time, in the morning and in the evening. You can do the exercise before going for a walk in the corridor in the morning and before going to sleep in the evening. Normal Breathing and Focusing on Breathing (3 minutes) Alternate Nose Breathing-Nadi Shodhana (15-20 times/6 minutes) Normal Breathing and Focusing on Breathing (3 minutes) Bhramari Pranayama-Bee Buzzing Sound(8-10 times/5 minutes) Normal Breathing and Focusing on Breathing (3 minutes)

Yoga-Based Breathing Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having colo-rectal surgery for the first time
• Have a mobile phone suitable for downloading the yoga-based breathing exercise video,
• Use the same type and dose of painkillers,
• No communication barrier
• Volunteer to participate in the study.

You may not qualify if:

• Using sleeping pills,
• Having a physical disability in doing breathing exercises,
• Being diagnosed with a psychiatric disease,
• Having been doing yoga breathing exercises for the last six month

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Karatay, Konya, 42020, Turkey (Türkiye)

Location

Related Publications (8)

• Ban KA, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, Grant MC, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Colorectal Surgery. Anesth Analg. 2019 May;128(5):879-889. doi: 10.1213/ANE.0000000000003366.

  PMID: 29649026 BACKGROUND

• Jaya P, Thakur A. Effect of Progressive Muscle Relaxation Therapy on Fatigue and Psychological Distress of Cancer Patients during Radiotherapy: A Randomized Controlled Trial. Indian J Palliat Care. 2020 Oct-Dec;26(4):428-432. doi: 10.4103/IJPC.IJPC_236_19. Epub 2020 Nov 19.

  PMID: 33623302 BACKGROUND

• Kirca K, Kutluturkan S. The effect of progressive relaxation exercises on treatment-related symptoms and self-efficacy in patients with lung cancer receiving chemotherapy. Complement Ther Clin Pract. 2021 Nov;45:101488. doi: 10.1016/j.ctcp.2021.101488. Epub 2021 Oct 2.

  PMID: 34619419 BACKGROUND

• Lev EL, Owen SV. A measure of self-care self-efficacy. Res Nurs Health. 1996 Oct;19(5):421-9. doi: 10.1002/(SICI)1098-240X(199610)19:53.0.CO;2-S.

  PMID: 8848626 BACKGROUND

• Scheepers ERM, Vink GR, Schiphorst AHW, Emmelot-Vonk MH, van Huis-Tanja LH, Hamakerl ME. Health-related quality-of-life trajectories during/after surgery and adjuvant chemotherapy in patients with colon cancer. Eur Geriatr Med. 2023 Jun;14(3):565-572. doi: 10.1007/s41999-023-00750-9. Epub 2023 Mar 25.

  PMID: 36964869 BACKGROUND

• Schmidt ME, Bergbold S, Hermann S, Steindorf K. Knowledge, perceptions, and management of cancer-related fatigue: the patients' perspective. Support Care Cancer. 2021 Apr;29(4):2063-2071. doi: 10.1007/s00520-020-05686-5. Epub 2020 Aug 29.

  PMID: 32860177 BACKGROUND

• Yin L, Fan L, Tan R, Yang G, Jiang F, Zhang C, Ma J, Yan Y, Zou Y, Zhang Y, Wang Y, Zhang G. Bowel symptoms and self-care strategies of survivors in the process of restoration after low anterior resection of rectal cancer. BMC Surg. 2018 Jun 4;18(1):35. doi: 10.1186/s12893-018-0368-5.

  PMID: 29866087 BACKGROUND

• Akin S, Can G, Durna Z, Aydiner A. The quality of life and self-efficacy of Turkish breast cancer patients undergoing chemotherapy. Eur J Oncol Nurs. 2008 Dec;12(5):449-56. doi: 10.1016/j.ejon.2008.07.006. Epub 2008 Oct 7.

  PMID: 18842460 RESULT

MeSH Terms

Conditions

Signs and Symptoms; Pain; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Fatma Gündogdu

  KTO Karatay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data obtained as a result of the research will be coded as 'A' and 'B' by the researcher and transferred to the computer. In order to prevent bias in the evaluation of the data, the analysis of the coded data will be carried out by an independent statistician, thus ensuring statistician blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Experimental group: A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery. 2. Control group: Continuity of routine treatment and care of the patients included in the control group will be ensured.

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: June 6, 2024
• Study Start: July 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)