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

NCT06955507 | Active Not Recruiting

• 1 other identifier: KSU-EBE-NB-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Episiotomy

Keywords

Birth; reflexology; perineal pain; fatigue; quality of recovery

Outcome Measures

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.

  up to 24. hours after birth

Study Arms (2)

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

EXPERIMENTAL

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

Not Applying Foot Reflexology to Primiparous Women Who Underwent Episiotomy

NO INTERVENTION

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

reflexology BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Our study consists of women who gave birth for the first time.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Necip Fazıl Hospital Maternity and Child Additional Service Building

Kahramanmaraş, Kahramanmaraş, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Two groups will be created as experimental and control groups among primiparous women who have undergone episiotomy, and reflexology will be applied to the women in the experimental group and will not be applied to the other group. Necessary questionnaires will be filled out in the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MIDWIFE

Model Details: Two groups will be created as experimental and control groups among primiparous women who have undergone episiotomy.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: May 2, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-02

Locations

TU (1)