Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06201143 |
| Other study ID # |
SirnakU |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2024 |
| Est. completion date |
July 29, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Sirnak Üniversitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
No study has been found in which kinesiology taping, mobilization and breathing exercises
were used regarding postoperative pain and postpartum comfort after cesarean section. This
study aims to determine the effects of kinesiology taping, mobilization and breathing
exercise on post-cesarean section pain and postpartum comfort.
The study will be conducted with three groups, two intervention groups and one control group.
It has been calculated that a minimum of 33 people in each group and 99 people in total will
be sufficient. Anticipating the possibility of data loss in the study, it was planned to
include 15% more patients (n = 114).
Research Questions Is there a difference in terms of pain between the groups that received
kinesiology taping, mobilization training and breathing exercises after cesarean section and
those that did not? Is there a difference in postpartum comfort level between the groups that
received kinesiology taping, mobilization training and breathing exercises after cesarean
section and those that did not? Is there a difference in terms of pain between groups with
and without post-cesarean mobilization training and breathing exercise? Is there a difference
in postpartum comfort level between groups with and without post-cesarean mobilization
training and breathing exercise?
Description:
This study was designed with quantitative research method. Randomized controlled experimental
design of quantitative research will be used in this study. It will be conducted with women
who are in the postoperative period after cesarean section and who volunteer to participate
in the research. The population of the research consists of women who were admitted to Şırnak
State Hospital gynecology clinic and had a cesarean section in the last year. The sample size
and power calculation required for the study were calculated with the G*Power Ver.3.1.9.2
program. It was calculated that 99 people would be sufficient. Anticipating the possibility
of data loss in the study, it was planned to include 15% more patients (n = 114). Thus, the
study was planned to be conducted with 38 participants in each group and 114 participants in
total. This research will be a randomized controlled trial. Randomization of the groups will
be done in a simple random manner using the website www.random.org. The study will be
conducted with three groups, two intervention groups and one control group. Participants will
be placed into groups according to the randomization list. Mothers who meet the sample
selection criteria and agree to participate in the research will be included in the research.
As a data collection tool; Introductory information form, Mobilization and Respiratory
Exercise Follow-up Chart, Visual Analogue Scale =VAS and Postpartum Comfort Scale will be
used.
COLLECTION OF DATA BREATHING EXERCISE AND MOBILIZATION TRAINING GROUP Pregnant women who are
admitted to the gynecology ward for cesarean section, who agree to participate in the study
and who meet the sample selection criteria will be assigned to the application group
according to the randomization list. Pregnant women will be interviewed before the cesarean
section, an explanation will be given about the purpose of the research, its content and the
methods to be applied, and an informed consent form will be obtained verbally and in writing.
Pregnant women will fill in the sections of the introductory information form questioning
sociodemographic and obstetric characteristics through face-to-face interviews. Mothers will
be asked to sleep in different rooms to prevent interaction with each other.
Breathing exercise and mobilization training will be given in the patient's room during
the preoperative period. Each training is planned to last approximately 20 minutes. During
the training, patients will be taught breathing and mobilization techniques in practice, will
be shown how to mark the breathing exercise and mobilization tracking chart, and their
questions will be answered.
The patient will be informed about techniques and points to consider regarding sitting on the
edge of the bed, standing up on the edge of the bed, and walking in the patient room, as well
as the time he/she will spend out of bed on the day of surgery and the first and subsequent
days after surgery.
The patient will be informed that he or she will need to be mobilized out of bed for 2 hours
on postoperative day 0 and for 6 hours on postoperative day 1 and thereafter. Six hours after
the surgery, the patient's first mobilization will be performed by the researcher. The
patient will be mobilized by planning the second and third mobilization at four-hour
intervals. Outside of planned mobilization hours, patients will be informed about
mobilization as long as they feel well.
The patient will be told that breathing exercises should be done on the day of surgery, on
the first and second days after surgery, when the patient is awake and able to move freely, 5
sets of 10 repetitions a day. Since pursed lip exercise is used in studies conducted after
abdominal surgery in the literature, pursed lip exercise will be taught in breathing exercise
training.
In order to increase lung expansion, the patient will be placed in the Fowler position and
instructed to take a slow deep breath through his nose, hold it in for two or three seconds,
and slowly purse his lips at the time of expiration. In line with the literature, breathing
exercises will be required to be performed 5 sets of 10 repetitions a day.
The patient will be taught to wait 1-2 seconds after each breath. A breathing exercise and
mobilization training brochure prepared in line with the literature will be given to the
patients.
VAS will be filled at the 10th postoperative hour. Simultaneously with the kinesiology taping
+ breathing exercise and mobilization training group, VAS will be filled in again 45 minutes
after the first VAS evaluation.
VAS measurements will be repeated at the 24th, 48th and 72nd hours postoperatively.
The first measurement of the postpartum comfort scale will be completed at the 10th
postoperative hour, and the second measurement will be completed at the 72nd postoperative
hour.
The mother will be asked to record the times of gas and stool passage and these will be
recorded in accordance with the patient's statement.
KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING GROUP; Pregnant women
who are admitted to the gynecology ward for cesarean section and who meet the research
criteria will be interviewed before the cesarean section, an explanation will be given about
the purpose of the research, its content and the methods to be applied, and verbal and
written informed consent forms will be obtained from those who wish to participate in the
study. Pregnant women will fill in the sections of the introductory information form
questioning their sociodemographic and past obstetric characteristics through face-to-face
interviews.
Breathing exercise and mobilization training will be given in the patient's room during
the preoperative period. Each training is planned to last approximately 20 minutes. During
the training, patients will be taught breathing and mobilization techniques in practice, will
be shown how to mark the breathing exercise and mobilization tracking chart, and their
questions will be answered.
The patient will be informed about techniques and points to consider regarding sitting on the
edge of the bed, standing up on the edge of the bed, and walking in the patient room, as well
as the time he/she will spend out of bed on the day of surgery and the first and subsequent
days after surgery.
The patient will be informed that he or she must provide out-of-bed mobilization for 2 hours
on postoperative day 0 and 6 hours on postoperative day 1 and thereafter.
On the day of surgery, the first mobilization of the patient will be performed by the
researcher six hours after the surgery. The patient will be mobilized by planning the second
and third mobilization at four-hour intervals. Outside of planned mobilization hours,
patients will be informed about mobilization as long as they feel well.
The patient will be told that breathing exercises should be done on the day of surgery, on
the first and second days after surgery, when the patient is awake and able to move freely, 5
sets of 10 repetitions a day.
In line with the literature, preoperative breathing exercise and mobilization training
booklet will be given to patients.
What happens in the 10th postoperative hour for kinesiology taping: In the first 10 hours
after the surgery, hypotension due to bleeding during the surgery and the effect of
anesthesia and the resulting weakness, headache due to dural puncture, dizziness, nausea and
vomiting, complaints of low back pain are frequently observed, numbness in the extremities is
observed in women, Kinesiology taping will be started postoperatively in order to remain
cognitively under the influence of anesthesia and to effectively apply measurement tools and
applications. Kinesiology tape comes in blue, cream, pink and black colors. The color choice
of the band is left to the patients' preference. I tape will be adhered around the
incision area with the web cutting technique, leaving the incision area open, using the space
conservation technique, without applying tension to the starting and ending points. After
application, the tape will be adhered to by hand movements.
In order to facilitate the patients' gas and stool passage, the I band will be turned
into a Y band, and four bands, two on the right and left, will be attached around the belly
with circulatory/lymphatic correction technique with 25% tension on the tails, without
tension at the starting point.
In line with the literature, VAS will be filled in immediately before kinesiology tape
applications (at 10 hours postoperatively) and 45 minutes after the application in order to
observe acute pain.
VAS measurements will be repeated at 24, 48 and 72 hours postoperatively. The first
measurement of the postpartum comfort scale will be completed at the 10th postoperative hour,
and the second measurement will be completed at the 72nd postoperative hour.
After completing the questionnaires, the tapes will be removed by the researcher using baby
oil.
During the study, patients' questions will be answered and counseling will be provided
during face-to-face meetings.
The mother will be asked to record the times of gas and stool passage and these will be
recorded in accordance with the patient's statement.
The structured information form, scales and kinesiology tape application steps will be
applied by the researcher who has completed the Kinesiotaping 1-2 Certificate Course.
CONTROL GROUP; Pregnant women who are admitted to the gynecology ward for cesarean section,
who agree to participate in the study and who meet the sample selection criteria will be
assigned to the application group according to the randomization list. Pregnant women will be
interviewed before the cesarean section, an explanation will be given about the purpose of
the research, its content and the methods to be applied, and an informed consent form will be
obtained verbally and in writing. Pregnant women will fill in the sections of the
introductory information form questioning their sociodemographic and past obstetric
characteristics through face-to-face interviews. Mothers will be asked to sleep in different
rooms to prevent interaction with each other.
