ReflexologyNCT06769958
The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy
A study testing Reflexology in people with Reflexology, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effects of reflexology applied to mothers with headache due to spinal anesthesia after Cesarean delivery on pain, comfort and breastfeeding self-efficacy levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Reflexology
- 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
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Aug 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years and older,
- performing SD under spinal anesthesia,
- experiencing postpartum headaches,
- Caesarean section performed at 37-42 weeks of gestation,
- giving only one live birth,
- open to written or oral communication,
Show all 9Show fewer
- at least a primary school graduate,
- no complications during pregnancy,
- mothers who agreed to participate in the study
Who cannot join
- Performing a cesarean section at periods other than 37-42 weeks of gestation,
- caesarean section under general anesthesia,
- have health problems such as fractures, dislocations, phlebitis, arthritis, burns, wounds, eczema, fungus or inflammation in the foot tissue,
- with disease of the cardiovascular system,
- with chronic diseases such as hypertension or diabetes mellitus,
- Postpartum controlled analgesia administered,
- mothers with psychiatric diagnoses such as anxiety and depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy in Post-Cesarean Headache Due to Spinal Anesthesia
This study was conducted to determine the effects of reflexology applied to mothers with headache due to spinal anesthesia after Cesarean delivery on pain, comfort and breastfeeding self-efficacy levels. The study, which was conducted with a single-blind, randomized controlled experimental design, was conducted between April 2024 and August 2024 at the Department of Obstetrics and Pediatrics, SBU Van Training and Research Hospital with mothers who had cesarean delivery under spinal anesthesia and had postpartum headache (Intervention group=30, Control group=30). Foot reflexology was applied to the mothers in the intervention group for a total of 30 minutes, 15 minutes on each foot. The control group was not subjected to any intervention other than routine nursing practices. Personal Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale (PPSC) and Breastfeeding Self-Efficacy Scale (BSSE) were used as data collection tools.
- Conditions
- Reflexology
- Being tested
- Reflexology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyBehavioural
Reflexology application
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | Not described Receives: Behavioral: Reflexology |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
min-max (0-10), an increased score is a bad result
Measured: pre-test post-test (approximately eight months), reduce pain
Postpartum Comfort Scale
min-max (34-170), increased score is a good result
Measured: pre-test post-test (approximately eight months), Increasing Postpartum Comfort
Breastfeeding Self-Efficacy Scale
min-max (14-70), increased score is a good result
Measured: pre-test post-test (approximately eight months), Increasing breastfeeding self-efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2024
- Primary completion20 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReflexologyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Can, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769958
- Sponsor's protocol ID
- Reflexology
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy in Post-Cesarean Headache Due to Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06769958
- Acronym / sponsor ID
- Reflexology
- Conditions
- Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 10 Jan 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.
This study was conducted to determine the effects of reflexology applied to mothers with headache due to spinal anesthesia after Cesarean delivery on pain, comfort and breastfeeding self-efficacy levels. The study, which was conducted with a single-blind, randomized controlled experimental design, was conducted between April 2024 and August 2024 at the Department of Obstetrics and Pediatrics, SBU Van Training and Research Hospital with mothers who had cesarean delivery under spinal anesthesia and had postpartum headache (Intervention group=30, Control group=30). Foot reflexology was applied to the mothers in the intervention group for a total of 30 minutes, 15 minutes on each foot. The control group was not subjected to any intervention other than routine nursing practices. Personal Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale (PPSC) and Breastfeeding Self-Efficacy Scale (BSSE) were used as data collection tools.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Behavioral: Reflexology |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 years and older,
- performing SD under spinal anesthesia,
- experiencing postpartum headaches,
- Caesarean section performed at 37-42 weeks of gestation,
- giving only one live birth,
Key exclusion criteria (7 listed)
- Performing a cesarean section at periods other than 37-42 weeks of gestation,
- caesarean section under general anesthesia,
- have health problems such as fractures, dislocations, phlebitis, arthritis, burns, wounds, eczema, fungus or inflammation in the foot tissue,
- with disease of the cardiovascular system,
- with chronic diseases such as hypertension or diabetes mellitus,
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 |
|---|---|---|
| ReflexologyReflexology application | Behavioural | Reflexology |
Primary outcome
Visual Analog Scale
Time frame: pre-test post-test (approximately eight months), reduce pain
min-max (0-10), an increased score is a bad result
Postpartum Comfort Scale
Time frame: pre-test post-test (approximately eight months), Increasing Postpartum Comfort
min-max (34-170), increased score is a good result
Breastfeeding Self-Efficacy Scale
Time frame: pre-test post-test (approximately eight months), Increasing breastfeeding self-efficacy
min-max (14-70), increased score is a good result
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
Premenstrual Syndrome-PMS
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 Reflexology, run by Yuzuncu Yil 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 9 inclusion and 7 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 10 Jan 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?
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 (time frame: pre-test post-test (approximately eight months), reduce pain). The study lists 3 primary outcomes in all. 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 10 Jan 2025.