NCT07091760

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

June 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

June 25, 2025

Last Update Submit

July 21, 2025

Conditions

Keywords

Caesarean sectionSu JokPainAnxietyComfortNursing

Outcome Measures

Primary Outcomes (5)

  • Personal Information Form

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

    10 months

  • 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.

    10 months

  • 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.

    10 months

  • 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.

    10 months

  • 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.

    10 months

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

No Intervention : Control group

NO INTERVENTION

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

Interventions

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.

Experimental Group

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.

Placebo Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgiving birth by caesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ayşe AYDIN

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Statistics expert, Participant
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 29, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations