Trial Title:
Yoga-Based Breathing Exercise, Colorectal Cancer Surgery
NCT ID:
NCT06446999
Condition:
Symptoms and Signs
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer surgery
Yoga-Based Breathing Exercise
Pain
Fatigue
İnsomnia
Self Efficacy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Yoga-Based Breathing Exercise
Description:
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)
Arm group label:
Yoga-Based Breathing Exercise
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.
Detailed description:
Colorectal cancers are the third most common type of cancer in terms of incidence
worldwide and the second leading cause of death. Surgical treatment, chemotherapy and
radiotherapy are generally used in the treatment of colorectal cancers. Side effects such
as pain, nausea-vomiting, intestinal problems, and fatigue may occur after colorectal
cancer surgery (CRCS). In addition, in patients who subsequently receive chemotherapy or
radiotherapy, these patients may experience symptom distress and their quality of life
may be negatively affected due to side effects such as nausea, vomiting, diarrhea,
malnutrition, peripheral neuropathy and fear of cancer recurrence. Pharmacological
methods in the management of fatigue are quite limited, and the effect of
non-pharmacological approaches such as cognitive behavioral therapies, relaxation,
exercise, training of patients and their relatives for fatigue management, exercise,
cognitive behavioral therapies, and meditation is effective. Studies evaluating it are
increasing. However, it has been stated that very few (10%) of cancer patients
experiencing severe fatigue do yoga to manage fatigue. This research was planned to
evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and
self-efficacy in individuals undergoing colorectal cancer surgery.
Type of Research: This study was designed as a prospective, parallel 3-group 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.
Place and Time of the Research: The research will be conducted at Necmettin Erbakan
University Meram Medical Faculty General Surgery Clinic between 01 September 2023 and 30
July 2024.
Population and Sample of the Research: The research population will consist of patients
who come for colorectal cancer surgery between 01 September 2023 and 30 July 2024 at
Necmettin Erbakan University Meram Faculty of Medicine General Surgery Clinic, where the
research will be conducted. The sample number of the study was determined according to
the results of a similar study with the G*Power 3.1., 9.7 program with α = 0.05 and 80%
power and 0.648 effect. The sample was determined as 50 patients, 25 patients in the
experimental group and 25 patients in the control group. Considering possible losses
during the study, it was planned to include a total of 60 patients, 30 patients in the
experimental group and 30 patients in the control group.
Data Collection Tools: "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.
VAS Pain Scale: It is a scale used to evaluate pain by giving a value between 0 and 10. A
score of 0 means no pain, and a score of 10 means unbearable pain. As the score
increases, the severity of pain increases.
Brief Fatigue Inventory: The scale evaluates the level of fatigue in the last 24 hours
and the reflection of this fatigue on activities in daily life (general activity, mood,
walking ability, work life, relationships with other people, joy of life). KYE; It
consists of a total of 9 items, 3 items assessing fatigue, general fatigue, and 6 items
assessing the impact of fatigue on daily life. Individuals score all items between "0"
(no fatigue at all) and "10" (the most severe fatigue you can experience), taking into
account the last 24 hours.
Richard Campbell Sleep Scale: The scale developed to determine sleep quality consists of
six items: depth of night sleep, time to fall asleep, frequency of waking up, time to
fall asleep when woken up, quality of sleep and noise level in the environment. Visual
analog scale technique was applied for all expressions. RCUÖ average value; Scale
variables are calculated by adding the mean scores and dividing by five. There is only a
total score in the scale and the evaluation is made on the average of this score. A total
score of the scale between 0 and 25 indicates poor sleep, and a score between 76 and 100
indicates good sleep. An increase in the total score average defines a positive increase
in sleep quality.
Health Promotion Strategies Used by Patients Scale: The health promotion strategies used
by patients scale was developed. This scale is a 29-item self-report scale. The scale,
which initially consisted of 36 items and 4 subscales, was rearranged in 2001. With the
factor analysis study called "Confirmatory Factor Analysis", the number of scale items
was reduced to 29 and 3 sub-dimensions were defined. These sub-dimensions are: coping
with stress, decision making and positive behavior. 1st to 10th of the scale. item,
coping with stress sub-dimension, 11th-13th. items decision-making sub-dimension,
14th-29th. The items are the positive behavior subdimension.
Implementation of the Research: Patients who will undergo CRC will be given verbal
information about the research before surgery, and those who agree to participate in the
research will be evaluated for compliance with the inclusion criteria. The purpose of the
research and how it will be implemented will be explained to the patient who meets the
criteria for inclusion in the research, and their written consent will be obtained.
Initial assessments will be made regarding sociodemographic and health history, VAS Pain
score, Fatigue, Insomnia and Self-Efficacy level before surgery/pre-intervention. After
the initial evaluation, patients will be assigned according to randomization. For the
second evaluation, the VAS Pain score, Fatigue, Insomnia and Self-Efficacy levels of the
control and experimental groups will be evaluated on the 4th day after surgery.
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.
Control group: Continuity of routine treatment and care of the patients included in the
control group will be ensured. The control group will be recruited before preoperative
assignment to patients. After the final test of the patients, information will be given
about breathing exercises, and patients who want to do breathing exercises will be
provided with a video link uploaded to their mobile phones.
Ethical Dimension of the Research: In order to conduct the research, ethics committee
approval was obtained from KTO Karatay University Non-Pharmaceutical and Non-Medical
Device Research Ethics Committee and permission was 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. To avoid bias, Clinical Trials protocol
registration will be made after obtaining permission from the ethics committee.
Statistical Evaluation of Research Data: The data will be evaluated in the IBM SPSS
Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) statistical
package program. Descriptive statistics will be given as number of units (n), percentage
(%), mean ± standard deviation, median (M), minimum (min) and maximum (max) values. The
normal distribution of the data of numerical variables will be evaluated with the Shapiro
Wilk normality test. Homogeneity of variances will be evaluated with the Levene test. To
evaluate the differences between two independent groups, "Student's t Test" is used when
parametric test prerequisites are met; When this could not be achieved, the "Mann
Whitney-U test" was used. A level of p<0.05 will be considered statistically significant.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
KTO Karatay University
Address:
City:
Karatay
Zip:
42020
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Fatma Gündogdu
Phone:
05303243824
Email:
fatma.gundogdu@karatay.edu.tr
Start date:
September 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
KTO Karatay University
Agency class:
Other
Source:
KTO Karatay University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06446999
