AzTrials
AzTrials

PainNCT06484309

Nonpharmacological Method for Relief During Episiotomy Repair

A study testing Reflexology Group in people with Pain, run by Kocaeli University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study was planned as a randomized controlled trial to evaluate the effect of reflexology on perceived perineal pain during episiotomy repair. The research will be carried out with participants who gave birth vaginally at Darıca Farabi Training and Research Hospital between July and December 2024. 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
Pain
What is being tested?
Reflexology Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Jul 2024to 30 Dec 2025
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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to read and write,
  • Those who have sufficient mental health to fill out the survey form,
  • Between the ages of 18-35,
  • Primiparous,
  • At term gestational age (37-42 weeks),
  • Having spontaneous birth with medial lateral episiotomy,
  • The baby is healthy (does not require intervention or treatment),
  • Participants who volunteered to participate in the study.

Who cannot join

  • Those with visual, hearing or perception impairments,
  • Having obstetric complications,
  • Those who are allergic to anesthetic drugs and latex,
  • Those with vaginal anomalies and signs of infection,
  • Those with lacerations other than episiotomy (anal sphincter injury or 3rd or 4th degree laceration),
  • Having an episiotomy smaller than 2 cm and larger than 4 cm,
Show all 10Show fewer
  • If the newborn is unhealthy or stillborn,
  • Having a newborn who needs oxygen support,
  • Possible bleeding or bleeding,
  • Participants requiring large amounts of anesthesia during episiotomy repair.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Darica Farabi Training and Research Hospital

    Kocaeli, 41000

  • Kocaeli University

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Reflexology on Perceived Perineal Pain During Episiotomy Repair.

The study was planned as a randomized controlled trial to evaluate the effect of reflexology on perceived perineal pain during episiotomy repair. The research will be carried out with participants who gave birth vaginally at Darıca Farabi Training and Research Hospital between July and December 2024. The research will be carried out with two groups: reflexology and control groups. Considering the sample size in the R pwrss (Statistical Power and Sample Size Calculation Tools) program, a type 1 (alpha) error of 0.05 and a power of 0.80, it was calculated that the study group should be at least 32 in the reflexology group and 32 in the control group. Considering the confounding variables, it was planned to recruit 25% more participants for each group, and therefore it was decided to recruit 40 participants per group. The participants included in the study will be divided into two groups by determining which group they will be included in from the website called "Random List", a random number generation program. Thus, each participant's number and group number will be determined and recorded. Research data will be collected using the Participant Information Form, VAS (Visual Analog Scale) and McGill Ağrı survey, which were created by the researcher within the framework of the literature on the subject. The data of the research will be evaluated using SPSS (IBM) 29.0 program. In evaluating the data; Descriptive statistics and comparative statistical analyzes will be used. Statistical significance level will be accepted as p<0.05.

Read the detailed description

Aim: To examine the effect of reflexology on perceived perineal pain during episiotomy repair.

Hypothesis(s):

H0: There is no difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair.

H1: There is a difference between the perineal pain of the group in which reflexology was applied and the group in which reflexology was not applied during episiotomy repair.

Type of Research: This study was designed as a randomized controlled experimental study.

In order to determine the sample size in the study, it was calculated according to the research conducted by Sharifi et al (2022). Considering the sample size in the R pwrss (Statistical Power and Sample Size Calculation Tools) program, a type 1 (alpha) error of 0.05 and a power of 0.80, it was calculated that the study group should be at least 32 in the reflexology group and 32 in the control group. Considering the confounding variables, it was planned to recruit 25% more participants for each group, and therefore it was decided to recruit 40 participants per group, 80 participants in total.

The participants included in the study will be divided into two groups by determining which group they will be included in from the website called "Random List", a random number generation program. Thus, each participant's number and group number will be determined and recorded.

Research data will be collected using the Participant Information Form, VAS (Visual Analog Scale) and McGill Pain questionnaire to assess pain during episiotomy repair.

Participant Information Form It was prepared by the researcher within the framework of the literature. The form consists of a total of 14 questions that question women's socio-demographic and obstetrics-related information.

VAS for Evaluation Pain during Episiotomy Repair: The participant marks his or her own pain on a 10 cm ruler, which is marked as "no pain" at one end and the most severe pain at the other end. The participant is told that there are two endpoints and to mark any place between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

McGill Short Form for Assessment of Pain Following Episiotomy Repair: The McGill Pain Questionnaire was developed by Melzack and Torgerson and is used to evaluate pain multidimensionally. There are 15 criteria by which pain is evaluated. 11 of these criteria are to evaluate the emotional dimension of pain, and 4 are to evaluate the perceptual dimension of pain. Assessment of pain was rated on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). In the first part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. Sensory pain score ranges from 0-33, perceptual pain score ranges from 0-12, and total pain score ranges from 0-45. An increase in the score indicates that the pain also increases. Second Part: In this part, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. Third Part: In the third part of MAS-CF, the patient's current pain intensity was evaluated using a visual comparison scale.

Application of Research After obtaining the necessary ethics committee and institutional permissions to conduct the research, the institution will be visited and participants who gave birth normally with episiotomy and meet the inclusion criteria for the study will be interviewed. Data will be collected by the researcher in the hospital delivery room. Women will be informed about the research and the purpose of the research will be explained. Those who agree to participate in the research will be asked to read and sign the Informed Consent Form. Participants who meet the criteria will be divided into reflexology and control groups. The website called "https://www.randomlists.com/", a random number generation program, will be used to determine the selection process. Thus, each participant's number and group number will be determined and recorded. Episiotomy repairs will be performed by the same midwife. We were going to do another investigative reflexology application. Data collection forms will be filled out by an independent midwife who is not involved in the research. One of the researchers, SDA, has approved international training and certification in the ability to apply foot reflexology techniques based on standard protocol.

For the reflexology group, first a 4-minute general massage will be applied to each foot, then a 2-minute specific reflexology will be applied in the form of rotational pressures to each point of the pelvis, sacrum, uterus and solar plexus. The application will take approximately 20-30 minutes. These points were agreed upon by experts in reflexology as effective points in reducing pain and anxiety. The control group will receive only general massage on each foot for 4 minutes.

Statistical analysis will be performed using IBM SPSS Statistic 29.0 (IBM Corp., Armonk, NY, USA). Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of socio-demographic data. When the data is found to be suitable for normal distribution, parametric tests (chi-square, T test, etc.) will be used to compare categorical variables, and when the data is not found to be suitable for normal distribution, non-parametric tests (Mann-Whitney U Test) will be used. Statistical significance level will be accepted as p<0.05.

Conditions
Pain
Being tested
Reflexology Group
Keywords
Episiotomy, Reflexology, vaginal birth
Medical subject headings
Pain

What participants receive

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

  • Reflexology GroupBehavioural

    • In the 3rd stage of labor, local anesthesia (5 ml lidocaine 2%) will be applied and episiotomy repair will begin.
    • Reflexology application will be started at the same time,
    • Reflexology application will continue for at least 20-30 minutes during the episiotomy repair until the episiotomy repair is completed,
    • Pain will be evaluated with VAS to determine the pain level four times in total: just before suturing, during perineal suturing (internal), during skin suturing and immediately after suturing is completed,
    • Approximately 15-20 minutes after the end of the episiotomy repair, a face-to-face interview will be held and the McGill Pain Questionnaire will be filled out.
Study groups in NCT06484309
Study groupRoleWhat they receive
Reflexology GroupExperimental* Participants will sign an informed voluntary consent form during the active phase of labor, * Group assignment will be made, * Participant Information Form will be filled in, * The study will continue if episiotomy is performed at birth; If episiotomy is not performed at birth, it will not be included in the study. * Episiotomy repair will be performed by CG after anesthesia (5 ml lidocaine 2%) is applied in the 3rd stage of labor, * Reflexology application will be performed during episiotomy repair, * Evaluation with VAS will be performed before repair, during perineal repair (internal), during skin repair and immediately after the repair is completed, * The McGill Pain Questionnaire will be completed 20 minutes after episiotomy repair.
Receives: Behavioral: Reflexology Group
Control groupNo intervention* Participants will sign an informed voluntary consent form during the active phase of labor, * Group assignment will be made, * Participant Information Form will be filled in, * The study will continue if episiotomy is performed at birth; If episiotomy is not performed at birth, it will not be included in the study. * Episiotomy repair will be performed by CG after anesthesia (5 ml lidocaine 2%) is applied in the 3rd stage of labor, * Evaluation with VAS will be performed before repair, during perineal repair (internal), during skin repair and immediately after the repair is completed, * The McGill Pain Questionnaire will be completed 20 minutes after episiotomy repair.

What is being measured

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

  1. Visual analog scale to assess episiotomy pain

    The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

    Measured: 5 minutes before episiotomy repair

  2. Visual analog scale to assess episiotomy pain

    The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

    Measured: 10 minutes after episiotomy repair begins

  3. Visual analog scale to assess episiotomy pain

    The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

    Measured: 20 minutes after episiotomy repair begins

  4. Visual analog scale to assess episiotomy pain

    The participant marks his or her pain on a 10 cm ruler; On one end it says no pain, on the other end it says worst pain. The participant is told that there are two extreme points and to mark any place between these points that corresponds to the severity of the pain. The distance between the pain stop and the point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in measuring pain intensity. VAS is more sensitive than the simple descriptive scale.

    Measured: 5 minutes after episiotomy repair is completed

Secondary outcomes (1)
  1. McGill Pain Questionnaire to assess episiotomy pain

    The McGill Pain Questionnaire consists of three parts. The first part contains 15 descriptive word groups containing the characteristics of pain. 11 of these evaluate the sensory dimension of pain, and 4 evaluate the perceptual dimension. These descriptive words were rated on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = excessive). In the first part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of pain. In the third part, pain intensity is evaluated using a visual comparison scale. An increase in the score indicates that the pain also increases.

    Measured: 20 minutes after episiotomy repair is completed

Timeline

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

  1. First posted3 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completion23 Oct 2025
  4. Study completion30 Dec 2025

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
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06484309
Sponsor's protocol ID
sdilek9
Status last verified
Feb 2026
First submitted
20 Jun 2024
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharifi N, Bahri N, Hadizadeh-Talasaz F, Azizi H, Nezami H, Tohidinik HR. A randomized clinical trial on the effect of foot reflexology performed in the fourth stage of labor on uterine afterpain. BMC Pregnancy Childbirth. 2022 Jan 21;22(1):57. doi: 10.1186/s12884-022-04376-w.

    PubMed 35062899

Questions about this trial

What is this clinical trial studying?

A study testing Reflexology Group in people with Pain, run by Kocaeli University at 2 sites 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 scale to assess episiotomy pain (time frame: 5 minutes before episiotomy repair). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06484309, which also lists 1 linked publication.

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 11 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in