Clinical trial NCT06955507: Effect of Foot Reflexology on Perineal Pain, Fatigue and Healing Quality in Primiparous Patients Undergoing Episiotomy
Official title: Effect of Foot Reflexology on Perineal Pain, Fatigue and Healing Quality in Primiparous Patients Undergoing Episiotomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Episiotomy
Keywords: Birth
reflexology
perineal pain
fatigue
quality of recovery
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be created as experimental and control groups among primiparous women who have undergone episiotomy.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Effect of Foot Reflexology on Perineal Pain, Fatigue and Quality of Recovery in Primiparous Women Undergoing Episiotomy
timeFrame: up to 24. hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaraş Necip Fazıl Hospital Maternity and Child Additional Service Building
Study officials:
References: