Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT07091760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Su Jok Application on Pain, Anxiety and Comfort Levels After Cesarean Section
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
The Effect of Su Jok Application on Pain, Anxiety and Comfort Levels After Cesarean Section
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective: To determine the effect of Su Jok application on pain, anxiety and comfort level after cesarean section. The research will be conducted as a randomized controlled experimental study with pretest-posttest control group
Detailed Description:
The research population will consist of women between the ages of 18-35 who had cesarean section between September 2025 and June 2026 in the Gynecology and Obstetrics Service of Muş State Hospital. For determining the sample size of the study, in the G Power 3.1.9.4 Package Program priori power analysis was used and for repeated measures, analysis of variance was used. It was determined that the sample size required for the study to exceed 80% power at a significance level of 0.05 with a 95% confidence interval and a medium effect size was 28. Considering the possibility of the women included in the study to leave the study voluntarily and to develop complications after cesarean delivery, it is planned to take 90 people (30 intervention, 30 placebo and 30 control). Inclusion criteria: Being between 18-35 years of age, having at least primary school education, not having any health problems (such as hypertension, tuberculosis, cancer), not having hearing and vision problems, having a cesarean section with regional anesthesia, being within the first 48 hours after the operation, not having any wounds or infectious diseases in their hands, not having a diagnosis of psychiatric disease, speaking Turkish, women who voluntarily agreed to participate in the study. Exclusion criteria: Postpartum hemorrhage, incomplete completion of the application stages, complications during the application process, voluntary withdrawal of the woman from the study. Among the women who meet the criteria for participation in the study and who voluntarily agree to participate in the study, 90 people determined according to the Protocol of Power analysis will be selected by simple randomization method. Then, it was planned to include 30 women in the intervention group, 30 women in the placebo group and 30 women in the control group by randomization method. The researcher will not be blinded due to the nature of the research. Blinding will be applied to the participants and the data statistician. Participants will not know which group they are in. When the research is completed, the data of the experimental, placebo and control groups (coded with the letters A, B and C) will be analyzed by a statistician independent of the research and the findings will be reported. This research is planned to be conducted in a double-blind study design in which the participants and the statistician will be blinded. CONSORT 2010 Flow Diagram instructions will be followed in the research process. "Personal Information Form", "Visual Analog Scale (VAS)", "Verbal Category Scale", "Spielberg State Anxiety Scale" and "Postpartum Comfort Scale" will be used to collect research data. The intervention tool used in the study; Women who have had cesarean delivery who agree to participate in the study will be determined according to the inclusion criteria and will be assigned to the intervention, placebo and control groups by randomization method. The study will start by having all three groups sign an informed consent form. Following the collection of pre-test data in the individuals included in the study; Su Jok massage and seed application will be applied to the intervention group. The placebo group will receive Su Jok massage and seed application to an area without organ reflection. The control group will receive only the routine practices of the institution without any intervention. The data will be collected by the researcher between September 2025 and June 2026 by face-to-face interview in the Gynecology and Obstetrics Service of Muş State Hospital. Filling out the forms will take an average of 5-10 minutes Process steps: Intervention group: Due to the duration of action of the analgesics used, Su Jok administration will be performed at least 4-6 hours after the surgical procedure. Patients who meet the inclusion criteria will be pre-tested before the application. In the pre-test; Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PPCS) will be completed face to face. After the forms are filled in, Su Jok application will be performed. Visual Analog Scale (Visual Analog Scale/VAS), Verbal Category Scale, Spielberg State Anxiety Scale, and Spielberg State Anxiety Scale will be applied 30 minutes after the end of the application and Visual Analog Scale (Visual Analog Scale/VAS), Verbal Category Scale, Spielberg State Anxiety Scale, and Postpartum Comfort Scale (PANCS) will be applied 6 hours later. Placebo Group: Due to the duration of action of the analgesics used, placebo administration will be performed at least 4-6 hours after the surgical procedure. Patients who meet the inclusion criteria will be pretested before the application. In the pre-test; Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PPCS) will be filled by face-to-face interviews. After the forms are filled in, Su Jok will apply massage and seed application to an area without organ reflection. Visual Analog Scale (Visual Analog Scale/VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Spielberg State Anxiety Scale will be applied 30 minutes after the application and Visual Comparison Scale (Visual Analog Scale/VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PANCS) will be applied 6 hours after the application. Control Group: Due to the duration of action of the analgesics used, the patient would be interviewed at least 4-6 hours after the surgical procedure. Only routine care of the clinic will be applied to the control group. The pre-test; Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PPCS) will be completed by face-to-face interviews for women who meet the inclusion criteria. Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale will be administered 30 minutes after the pre-test data collection and Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale will be administered 6 hours later. PSS 25 package program will be used for coding and evaluation of the data. Number, percentage, mean and standard deviation will be used to analyze the data. Normality tests of the data will be evaluated with kurtosis and skewness coefficients. Chi-Square test and independent groups t Test / Mann-Whitney U test or ANOVA / Kruskal Wallis will be used to evaluate the averages and categorical data of the scores obtained with the scales. For repeated measurements, dependent groups t Test / Wilcoxon test or ANOVA / Fridman test will be used. A significance level of p\<0.05 will be accepted. The internal validity of the scales will be determined by Cronbach α coefficient. Cohen's d/eta squared value will be calculated for t-test in dependent and independent groups for the effect size of the change in scale scores. All ethical principles will be followed throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: