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Caesarean SectionNCT07091760

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

A study testing Su Jok Application in people with Caesarean Section, run by Ataturk University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Caesarean Section
What is being tested?
Su Jok Application
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • Postpartum hemorrhage
  • Incomplete completion of the application stages
  • Complications during the application process
  • Voluntary withdrawal of the woman from the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Ataturk University

    Erzurum

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Being tested
Su Jok Application, Placebo Application
Keywords
Caesarean section, Su Jok, Pain, Anxiety, Comfort, Nursing
Medical subject headings
Pain, Anxiety Disorders

What participants receive

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

  • Su Jok ApplicationOther

    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 ApplicationOther

    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.

Study groups in NCT07091760
Study groupRoleWhat they receive
Experimental GroupExperimentalA "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.
Receives: Other: Su Jok Application
Placebo GroupPlacebo comparatorDue 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.
Receives: Other: Placebo Application
No Intervention : Control groupNo interventionDue 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 being measured

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

  1. Personal Information Form

    There are 21 questions in this form, prepared by the researchers in line with the literature

    Measured: 10 months

  2. Visual Analog Scale (VAS)

    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.

    Measured: 10 months

  3. Verbal Category Scale

    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.

    Measured: 10 months

  4. Spielberg State Anxiety Scale

    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.

    Measured: 10 months

  5. Postpartum Comfort Scale

    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.

    Measured: 10 months

Timeline

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

  1. First posted29 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091760
Sponsor's protocol ID
Leyla Ertekin Tastan
Status last verified
Jul 2025
First submitted
25 Jun 2025
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
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 Su Jok Application in people with Caesarean Section, run by Ataturk University at 1 site in Turkey (Türkiye).

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 9 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayşe AYDIN (+905434668220, aysea@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal Information Form (time frame: 10 months). The study lists 5 primary outcomes in all. 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 29 Jul 2025.

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