EpisiotomyNCT06955507
Effect of Foot Reflexology on Perineal Pain, Fatigue and Healing Quality in Primiparous Patients Undergoing Episiotomy
A study testing reflexology in people with Episiotomy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy
- What is being tested?
- reflexology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Necip Fazıl Hospital Maternity and Child Additional Service Building
Kahramanmaraş, Kahramanmaraş, 46000
About this study
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.
- Conditions
- Episiotomy
- Being tested
- reflexology
- Keywords
- Birth, reflexology, perineal pain, fatigue, quality of recovery
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexologyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24. hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Feb 2025
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be created as experimental and control groups among primiparous women who have undergone episiotomy.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neziha Bayazıt, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955507
- Sponsor's protocol ID
- KSU-EBE-NB-01
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Reflexology on Perineal Pain, Fatigue and Healing Quality in Primiparous Patients Undergoing Episiotomy
- ClinicalTrials.gov ID
- NCT06955507
- Acronym / sponsor ID
- KSU-EBE-NB-01
- Conditions
- Episiotomy
- Keywords
- Birth, reflexology, perineal pain, fatigue, quality of recovery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups will be created as experimental and control groups among primiparous women who have undergone episiotomy.
| Arm | Type | Receives |
|---|---|---|
| Experimental group to apply foot reflexology technique to primiparas who underwent episiotomy | Experimental | Behavioral: reflexologyFirst 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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",
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflexologyFoot 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 | Behavioural | Experimental group to apply foot reflexology technique to primiparas who underwent episiotomy |
Primary outcome
Effect of Foot Reflexology on Perineal Pain, Fatigue and Quality of Recovery in Primiparous Women Undergoing Episiotomy
Time frame: up to 24. hours after birth
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology in people with Episiotomy, run by Kahramanmaras Sutcu Imam University at 1 site 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of Foot Reflexology on Perineal Pain, Fatigue and Quality of Recovery in Primiparous Women Undergoing Episiotomy (time frame: up to 24. hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.