The Effect of Su Jok Application on Pain, Anxiety and Comfort Levels After Cesarean Section

July 21, 2025 updated by: Ayse Aydin, Ataturk University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 problem
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
A "Su Jok Therapy" training certificate was obtained by the researcher for the application of Su Jok as a nursing intervention. Due to the duration of action of the analgesics used, Su Jok application will be performed at least 4-6 hours after the surgical procedure. A personal information form will be filled out to determine the descriptive characteristics of the patients who meet the inclusion criteria before the application. Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PPCS) will be applied to determine the pain, anxiety and comfort levels of women before the application. Pain and anxiety levels will be determined 30 minutes after the Su Jok massage and seed application, and pain, anxiety and comfort levels will be determined 6 hours later.
Other: Su Jok Application
The patient's hands will be preferred for the application due to the comfort and convenience of the woman after cesarean section. Su Jok therapy, massage and seed will be applied to the reflection points on the hand based on the area to be treated.
Placebo Comparator: Placebo Group
Due to the duration of action of the analgesics used, Su Jok application will be performed at least 4-6 hours after the surgical procedure. Patients who meet the inclusion criteria will fill out a personal information form to determine their descriptive characteristics before the application. Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PPCS) will be applied to determine the pain, anxiety and comfort level of the woman before the application. Pain and anxiety levels will be determined 30 minutes after Su Jok massage and seed application to the area without organ reflection, and pain, anxiety and comfort levels will be determined 6 hours later.
Other: Placebo Application

Placebo Intervention:

The placebo group will be massaged and seed will be applied to an area where there is no reflection of the Su Jok organ.
No Intervention: No Intervention : Control group
Due to the duration of action of the analgesics used, the patient will be interviewed at least 4-6 hours after the surgical procedure. Only routine care of the clinic will be applied to the control group. A Personal Information Form will be filled out to determine the descriptive characteristics of women who meet the inclusion criteria. Afterwards, Visual Analog Scale (VAS), Verbal Category Scale, Spielberg State Anxiety Scale and Postpartum Comfort Scale (PPCS) will be completed face to face to determine the level of pain, anxiety and comfort. Pain and anxiety levels will be determined 30 minutes after the pre-test data collection and pain, anxiety and comfort levels will be determined 6 hours later

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Personal Information Form
Time Frame: 10 months
There are 21 questions in this form, prepared by the researchers in line with the literature
10 months
Visual Analog Scale (VAS)
Time Frame: 10 months
The Visual Analog Scale is an assessment tool in which patients mark on a 10 cm ruler. The 10 cm scale, which is a numerical pain assessment scale, starts with "No pain (0)" and ends with "Intolerable pain (10)". The patient is asked to mark the place on the line that expresses pain. The distance marked by the patient is measured by taking zero as the starting distance. In this way, the patient's pain level is determined. In this study, a horizontal VAS will be used to assess pain intensity. The reason for choosing this scale in the study is that it is easy to understand and easy to use by the participants.
10 months
Verbal Category Scale
Time Frame: 10 months
The scale is based on the selection of the most appropriate word to describe the patient's pain condition. The pain of the patients is evaluated with the scoring method 'No Pain 0 points, Very Mild Pain 2 points, Mild Pain 4 points, Severe Pain 6 points, Very Severe Pain 8 points, Unbearable Pain 10 points'. The patient will be asked to select the appropriate pain level. The scale is easy to apply and easy to classify.
10 months
Spielberg State Anxiety Scale
Time Frame: 10 months
This scale was developed by Spielberger et al. Developed by. The adaptation of the scale to Turkish and its validity and reliability studies were carried out by Öner and Le Compte in 1983.The scale is a 4-point Likert scale consisting of the options "not at all", "somewhat", "a lot", "completely". There are 10 direct and 10 reversed statements in the scale. Positive (increasing the total anxiety score) for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18 in the scale; 1, 2, 5, 8, 10, 11, 15, 16, 19 Negative scores (reducing the total anxiety score) are obtained for the 20th items. The highest score is 80 and the lowest score is 20. A high total score indicates that the person's anxiety level is also high.Cronbach's alpha coefficient was found to be 0.79 for state anxiety. In this study, Cronbach's Alpha value was found to be 0.83.
10 months
Postpartum Comfort Scale
Time Frame: 10 months
The scale developed by Karakaplan and Yıldız (2010) to determine women's comfort after cesarean delivery and vaginal delivery is Likert-type and consists of 34 items. Each item is scored between "strongly disagree" (1 point) and "strongly agree" (5 points). The lowest score that can be obtained from the scale is 34 and the highest score is 170. The scale consists of three sub-dimensions (physical, psychosocial and sociocultural). An increase in the score obtained from the scale indicates an increase in comfort. Cronbach Alpha internal consistency coefficient was calculated as 0.78.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ayşe AYDIN, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Leyla Ertekin Tastan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings