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NurseCaesareaNCT06201143

The Effect of kınesıologıcal tapıng, mobılızatıon and breathıng exercıse on paın and Comfort After Caesarea

A study testing BREATHING EXERCISE AND MOBILIZATION TRAINING and KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING in people with Nurse and Cesarean Section, run by Şırnak Üniversitesi.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Nurse, Cesarean Section, Postpartum Comfort
What is being tested?
BREATHING EXERCISE AND MOBILIZATION TRAINING and KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
No sites listed yet
Study dates
10 Feb 2024to 29 Jul 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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must be in the 18-45 age group 37-40. There should be a cesarean section during the gestational week. Should not have a chronic disease Must not have a dermatological disease

Who cannot join

  • Deep vein thrombosis, open wound or skin irritation, etc.), Participants whose babies were taken to the neonatal intensive care unit

About this study

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?

Read the detailed 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.

Being tested
BREATHING EXERCISE AND MOBILIZATION TRAINING, KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING
Keywords
pain, nurse, kinesiology taping, pospartum comfort, breathing exercise, mobilization
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BREATHING EXERCISE AND MOBILIZATION TRAININGOther

    After cesarean mobilization and breathing exercise training, the number of breathing exercises performed and the duration of mobilization will be recorded. Thus, the effectiveness of the training will be examined in detail.

  • KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAININGOther

    It will be the first study to use kinesiotaping, breathing exercise and mobilization training together.

Study groups in NCT06201143
Study groupRoleWhat they receive
BREATHING EXERCISE AND MOBILIZATION TRAINING GROUPExperimentalBreathing 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. Respiratory and mobilization training for patients during training techniques will be taught in practice, they will be shown how to mark the breathing exercise and mobilization tracking chart, and their questions will be answered. Individuals in this group will be given breathing exercise and mobilization training. VAS form will be filled in at the 10th, 24th, 48th and 72nd hours of postpartum. The patient\'s total mobilization time and the number of breathing exercises will be recorded. The postpartum comfort scale will be filled in at the 10th and 72nd hours.
Receives: Other: BREATHING EXERCISE AND MOBILIZATION TRAINING
KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING GROUPExperimentalParticipants in this group will be given kinesiology taping, breathing exercise and mobilization training. Kinesiological taping will be done at the 10th hour postoperatively. The VAS form will be filled out at the 10th, 24th, 48th and 72nd postoperative hour. The patient\'s total mobilization time and the number of breathing exercises will be recorded. The postpartum comfort scale will be filled in at the 10th and 72nd hours.
Receives: Other: BREATHING EXERCISE AND MOBILIZATION TRAINING; Other: KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING
CONTROL GROUPNo interventionNo intervention will be made to individuals participating in this group. The VAS form will be filled out at the 10th, 24th, 48th and 72nd postoperative hour. The patient\'s total mobilization time and the number of breathing exercises will be recorded. The postpartum comfort scale will be filled in at the 10th and 72nd hours.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Skala

    "Participants obtained a response when they rated 0 or 10 performance states on a scale ranging from 0 (best outcome) to 10 (worst outcome).

    Measured: It will be filled in at the 10th, 24th, 48th and 72nd postoperative hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start10 Feb 2024 (estimated)
  3. Primary completion15 Jul 2024 (estimated)
  4. Study completion29 Jul 2024 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06201143
Sponsor's protocol ID
SirnakU
Acronym
Caesarea
Status last verified
Jan 2024
First submitted
30 Dec 2023
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BREATHING EXERCISE AND MOBILIZATION TRAINING and KINESIOLOGICAL TAPING + BREATHING EXERCISE AND MOBILIZATION TRAINING in people with Nurse and Cesarean Section, run by Şırnak Üniversitesi.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Visual Analog Skala (time frame: It will be filled in at the 10th, 24th, 48th and 72nd postoperative hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Jan 2024.

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