CClinicalTrials.gg
Active, not recruitingNCT06955507Updated May 2, 2025

Effect of Foot Reflexology on Perineal Pain, Fatigue and Healing Quality in Primiparous Patients Undergoing Episiotomy

An interventional study of reflexology in Episiotomy, sponsored by Kahramanmaras Sutcu Imam University. Active, not recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study summary

The act of giving birth can expose women to many risks during pregnancy and the birth process. It causes long-term emotional problems in pregnant women who experience labor pain and negatively affects their mental health. Episiotomy is a method applied to facilitate the birth of the baby by enlarging the vaginal opening. The postpartum period can significantly affect the lives of every mother, especially mothers who have had an episiotomy and vaginal birth. Many factors such as pain, fatigue and the negative effects of anesthetic drugs can negatively affect postpartum comfort and breastfeeding, causing late mother-baby bonding. With the support and information given to women during this period, women can be helped to make healthier and more accurate choices. They increasingly prefer natural methods to cope with problems that arise after birth. Some methods are used to accelerate recovery and prevent potential problems. Reflexology is an energy balancing system and special pressure method applied to reflex points with rubbing, squeezing and patting movements to increase rapid recovery.

Read the detailed description

The researcher will apply the face-to-face interview method to women who have undergone episiotomy in the postpartum ward located within the additional service building of Kahramanmaraş Necip Fazıl City Hospital, Maternity and Child.

Experimental Group;

First Measurement: Personal Information Form, VAS and YİGBÖ will be applied 3 hours after birth. Then, the first foot reflexology lasting on average 30 minutes will be applied to these women.

Second Measurement: Immediately after the first foot reflexology, the pain intensity will be re-evaluated with VAS.

Third Measurement: 15 hours after birth, the pain level will be re-evaluated with VAS and then the experimental group will be applied foot reflexology for a second time lasting on average 30 minutes.

Fourth Measurement: VAS and YİGBÖ will be applied immediately after the second foot reflexology.

Fifth Measurement: DSİKÖ will be filled in at the 24th hour.

Control Group; First Measurement: Personal Information Form, VAS and YİGBÖ will be applied 3 hours after birth.

Second Measurement: The pain intensity will be re-evaluated with VAS immediately after the first foot reflexology simultaneously with the foot reflexology application schedule applied to the experimental group.

Third Measurement: The pain level will be re-evaluated with VAS 15 hours after birth.

Fourth Measurement: VAS and YİGBÖ will be applied immediately after the second foot reflexology simultaneously with the foot reflexology application schedule applied to the experimental group.

Fifth Measurement: DSİKÖ will be filled in before discharge at the 24th hour. Foot Reflexology Application Procedure Foot reflexology will be applied by the researcher Neziha BAYAZIT, who will receive training on this subject, in the quietest and most comfortable position possible. Foot reflexology will be applied to the women in the experimental group by the researcher. The researcher will receive training on foot reflexology before the study. In the clinic where the study will be conducted, the foot reflexology application hours will be determined considering the analgesic treatment protocol applied. Accordingly, analgesic treatment is routinely applied to women who will receive foot reflexology at the 4th hour according to hospital procedure. Foot reflexology will be applied by the researcher at least 1 hour before the procedure analgesic treatment (3-15 hours after birth). The first foot reflexology will be applied at 3 hours after birth and the same foot reflexology will be repeated 12 hours later at 15 hours. Each woman will be given an explanation before the application. Foot reflexology will be applied in the patient rooms. The application will take approximately 30 minutes.

02

Conditions studied

  • Episiotomy

Browse trials for

Keywords

  • Birth
  • reflexology
  • perineal pain
  • fatigue
  • quality of recovery
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 68 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being over 18 years old,
  • Being literate,
  • Having a gestational age of 37-42 weeks,
  • Having a newborn weighing between 2500-4000 grams,
  • Expressing that perineal pain is "moderate" or "severe",
  • Being open to communication.

Exclusion criteria

Exclusion Criteria:

  • No other lacerations (anal sphincter injury, 3rd degree perineal laceration) other than episiotomy,
  • Newborn weighing between 2500-4000 grams,
  • Perineal pain stated as "moderate" or "severe",
  • No complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to neonatal intensive care unit, etc.),
  • No cognitive problems,
  • No conditions that make reflexology application undesirable such as thrombophlebitis, deep vein thrombosis, epilepsy, febrile illnesses, etc.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Experimental group to apply foot reflexology technique to primiparas who underwent episiotomy

    First Measurement: Personal Information Form, VAS and YİGBÖ will be applied 3 hours after birth. Then, the first foot reflexology lasting on average 30 minutes will be applied to these women. Second Measurement: Immediately after the first foot reflexology, the pain intensity will be re-evaluated with VAS. Third Measurement: 15 hours after birth, the pain level will be re-evaluated with VAS and then the experimental group will be applied a second foot reflexology lasting on average 30 minutes. Fourth Measurement: VAS and YİGBÖ will be applied immediately after the second foot reflexology. Fifth Measurement: DSİKÖ will be filled in at the 24th hour.

    Behavioral: reflexology

  • No intervention
    Not Applying Foot Reflexology to Primiparous Women Who Underwent Episiotomy

    First Measurement: Personal Information Form, VAS and YİGBÖ will be applied 3 hours after birth. Second Measurement: Pain intensity will be re-evaluated with VAS immediately after the first foot reflexology simultaneously with the foot reflexology application chart applied to the experimental group. Third Measurement: Pain level will be re-evaluated with VAS 15 hours after birth. Fourth Measurement: VAS and YİGBÖ will be applied simultaneously with the foot reflexology application chart applied to the experimental group and immediately after the second foot reflexology. Fifth Measurement: DSİKÖ will be filled out at the 24th hour before discharge.

Interventions

  • Behavioralreflexology

    Foot reflexology will be applied by the researcher Neziha BAYAZIT, who will receive training on this subject, in the quietest and most comfortable position possible. Foot reflexology will be applied by the researcher to the women in the experimental group. The researcher will receive training on foot reflexology before the study. In the clinic where the study will be conducted, the hours of foot reflexology application will be determined considering the analgesic treatment protocol applied. Accordingly, analgesic treatment is routinely applied to the women who will receive foot reflexology at the 4th hour according to hospital procedure. Foot reflexology will be applied by the researcher at least 1 hour before the analgesic treatment (3rd hour - 15th hour after birth). The same foot reflexology will be repeated 12 hours later at the 15th hour after the first foot reflexology is performed at the 3rd hour after birth. Each woman will be given an explanation before the application. Foot r

06

What researchers measure

Primary outcomes

  1. Effect of Foot Reflexology on Perineal Pain, Fatigue and Quality of Recovery in Primiparous Women Undergoing Episiotomy

    In primiparas who underwent episiotomy, the experimental group was the group to which foot reflexology was applied, while the control group was the group to which foot reflexology was not applied. A personal information form, Visual Analog Scale and Visual Similarity Scale for Fatigue will be filled out for both groups. The VAS is numbered from 0 to 10. Findings have shown that VAS ratings of 0 to 4 mm per 100 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. Scale ratings assess the effect of foot reflexology on episiotomy.

    Time frame: up to 24. hours after birth

07

Study locations

1 site
  • Kahramanmaraş Necip Fazıl Hospital Maternity and Child Additional Service Building
    Kahramanmaras, 46000, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06955507
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Neziha Bayazıt (MIDWIFE, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
May 2, 2025
Start date
Feb 1, 2025
Primary completion
Jun 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
May 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion