MassageNCT07045675
The Effect of Foot Reflexology Massage on the Perception of Labor Pain in Nulliparous Pregnant Women
An observational study of Massage and Labor Pain, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of reflexology massage, which is a non-pharmacological tool based on the effect of reflexology massage applied to the foot, on the perception of labor pain, on the perception of labor pain. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Massage, Labor Pain, Foot Massage
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2024to 28 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: 717
Who may be able to join
- Having a single, live fetus in vertex position
- Being in the latent phase of labor
- Cervical dilation is less than 5 cm
- Planning vaginal birth
- No pregnancy complications
- Contractions have started and are regular
Show all 9Show fewer
- No language problems
- Able to communicate verbally
- Pregnant women who agree to work.
Who cannot join
- Narcotic analgesic or sedative area
- Those with systemic diseases such as heart disease, hypertension, diabetes, kidney disease
- Pregnant women with pregnancy complications (placenta previa, preeclampsia, oligohydramnios, polyhydramnios, position/presentation disorder, etc.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, Istanbul, 34303
About this study
To evaluate the effect of reflexology massage, which is a non-pharmacological tool based on the effect of reflexology massage applied to the foot, on the perception of labor pain, on the perception of labor pain.
Read the detailed description
This research; It was planned as an experimental prospective randomized controlled clinical study to determine the effect of reflexology massage applied with the relaxation technique in the first stage of labor on perceived labor pain.
hypotheses H₁; There is a difference in perceived labor pain between the experimental group that received reflexology massage during labor and the control group.
H₂; There is a difference in birth times between the experimental group and the control group, which received reflexology massage during labor.
H₃; There is a difference in the level of state anxiety between the experimental group and the control group, which received reflexology massage during labor.
H₄; There is a difference in the level of postpartum fatigue between the experimental group and the control group, which received reflexology massage during labor.
H₅; There is a difference in the level of birth satisfaction between the experimental group and the control group, which received reflexology massage during labor.
H₆; There is a difference between the experimental group, which received reflexology massage during labor, and the control group, in terms of the time it takes to initiate breastfeeding in the postpartum period.
H₇; There is a difference in comfort levels at birth between the experimental group and the control group, which received reflexology massage during labor.
- Conditions
- Massage, Labor Pain, Foot Massage, Refleksoloji
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Pregnant women in this group start foot massage when the cervix is 3-4 cm dilated, and this massage is applied 3 times until birth, once when the cervix is 5-8 cm dilated and once when the cervix is 9-10 cm dilated. Massage time for each application is approximately 15 minutes for each foot. Pregnant women who agreed to participate in the study were given "Pregnant Introduction Form", "Labor Monitoring Form", "Visual Analogue Scale (VAS)", "Birth Comfort Scale", "State Anxiety Scale", "Postpartum Evaluation Form" and "Birth Satisfaction Scale". "Short Form (DÖ-SHORT FORM)" forms are filled out. | |
| control group | Massage is not applied to pregnant women in this group. Only forms are filled out. Pregnant women who agreed to participate in the study were given "Pregnant Introduction Form", "Labor Monitoring Form", "Visual Analogue Scale (VAS)", "Birth Comfort Scale", "State Anxiety Scale", "Postpartum Evaluation Form" and "Birth Satisfaction Scale". "Short Form (DÖ-SHORT FORM)" forms are filled out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vizüel Analog Skala (VAS)
The most common VAS consists of a 10 cm horizontal or vertical line with two ends labeled "no pain" and "worst possible pain" (or similar verbal descriptors). Patients are asked to place a mark on a point on a 10 cm line that corresponds to the level of pain intensity they feel. The distance in centimeters from the lower end of the VAS to the mark placed by the patient is used as the numerical value of pain intensity.
Measured: from the 1st stage of labor to birth
Pregnant Introduction Form
By scanning the literature, there are a total of 39 questions: 10 questions covering the sociodemographic characteristics of the pregnant woman, 17 questions covering her medical and obstetric characteristics, and 12 questions covering her knowledge and thoughts about birth.
Measured: from the 1st stage of labor to the 2nd hour after birth
Labor Follow-up Form
In the labor follow-up form; week of gestation, date and time when labor pains started, medications and applications administered in the first stage of labor, table of evaluations before and after reflexology massage application (cervical dilatation and effacement, head level and condition of membranes, intensity and frequency of contractions, fetal heart rate ( FKA), the mother's vital signs and behaviors during labor), the start time of the 2nd stage, the end time, the total duration of labor, questions regarding the first evaluation of the newborn (baby's gender, head circumference, weight, height, APGAR score and health status, initiation of the first breastfeeding and the mother's breastfeeding status).
Measured: from the 1st stage of labor to the 2nd hour after birth
Birth Comfort Scale
It consists of questions about pregnant women's opinions about their birth comfort during VM. The Cronbach Alpha coefficient of the scale was found to be 0.75. 24 The Cronbach Alpha coefficient of this study was found to be 0.72. The scale consists of 9 questions and is in the 5-point Likert type (1 = Totally disagree, 2 = Mostly disagree, 3 = Partially agree, 4 = Mostly agree, 5 = Completely agree). It is expected that the items will be answered considering the comfort in the delivery room. Each expression communicates a specific feeling of comfort (relaxation, relief, or superiority) and dimensions (physical, environmental, psychospiritual, or social). A minimum of 9 and a maximum of 45 points are obtained from the scale. It is stated that as the
Measured: from the 1st stage of labor to the 2nd hour after birth
Postpartum Evaluation Form
Postpartum evaluation form; It was prepared to evaluate the birth process for participants in the DSO group and control group. It is administered at the 2nd hour after birth and includes questions about the pregnant woman's thoughts about this birth, her thoughts about labor pain, how they feel after birth, and their satisfaction with the practices performed during labor.
Measured: from the 1st stage of labor to the 2nd hour after birth
Birth Satisfaction Scale Short Form
The Short Form of the Childbirth Satisfaction Scale is a 10-question, 5-point Likert-type scale, consisting of 3 sub-dimensions: "quality of care", "stress during labor" and "personal characteristics of the woman". The "quality of care services" sub-dimension is measured with items 3, 5, 6 and 10, the "stress during labor" sub-dimension with items 1, 2, 7 and 9, and the "personal characteristics of the woman" sub-dimension with items 4 and 8. It is scored as "strongly disagree" (0 points), "disagree" (1 point), "undecided" (2 points), "agree" (3 points), and "strongly agree" (4 points). Scores range from 0 to 40 on the scale, and as the score increases, the satisfaction level increases; low satisfaction <13 points, medium satisfaction 14-27 points, and high satisfaction ≥28 points. 6 items in the scale are positive, 4 items are negative, and 4 items (2nd, 4th, 7th, 8th) are scored in reverse. The Cronbach alpha level of the scale was found to be 0.682.
Measured: from the 1st stage of labor to the 2nd hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 Jan 2024
- Primary completion28 Oct 2025 (estimated)
- Study completion28 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurgül Kılıçaslan, Atlas University
- Investigators
- nurgül kılıçaslan, Principal investigator, İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045675
- Sponsor's protocol ID
- AU-EY-NK-01
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision will be made according to the study results.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology Massage on the Perception of Labor Pain in Nulliparous Pregnant Women
- ClinicalTrials.gov ID
- NCT07045675
- Acronym / sponsor ID
- AU-EY-NK-01
- Conditions
- Massage, Labor Pain, Foot Massage, Refleksoloji
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 28 Oct 2025 (estimated)
- Study completion
- 28 Oct 2025 (estimated)
- First posted
- 1 Jul 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.
To evaluate the effect of reflexology massage, which is a non-pharmacological tool based on the effect of reflexology massage applied to the foot, on the perception of labor pain, on the perception of labor pain.
Detailed description
This research; It was planned as an experimental prospective randomized controlled clinical study to determine the effect of reflexology massage applied with the relaxation technique in the first stage of labor on perceived labor pain.
hypotheses H₁; There is a difference in perceived labor pain between the experimental group that received reflexology massage during labor and the control group.
H₂; There is a difference in birth times between the experimental group and the control group, which received reflexology massage during labor.
H₃; There is a difference in the level of state anxiety between the experimental group and the control group, which received reflexology massage during labor.
H₄; There is a difference in the level of postpartum fatigue between the experimental group and the control group, which received reflexology massage during labor.
H₅; There is a difference in the level of birth satisfaction between the experimental group and the control group, which received reflexology massage during labor.
H₆; There is a difference between the experimental group, which received reflexology massage during labor, and the control group, in terms of the time it takes to initiate breastfeeding in the postpartum period.
H₇; There is a difference in comfort levels at birth between the experimental group and the control group, which received reflexology massage during labor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –Pregnant women in this group start foot massage when the cervix is 3-4 cm dilated, and this massage is applied 3 times until birth, once when the cervix is 5-8 cm dilated and once when the cervix is 9-10 cm dilated. Massage time for each application is approximately 15 minutes for each foot. Pregnant women who agreed to participate in the study were given "Pregnant Introduction Form", "Labor Monitoring Form", "Visual Analogue Scale (VAS)", "Birth Comfort Scale", "State Anxiety Scale", "Postpartum Evaluation Form" and "Birth Satisfaction Scale". "Short Form (DÖ-SHORT FORM)" forms are filled out. |
| control group | – | –Massage is not applied to pregnant women in this group. Only forms are filled out. Pregnant women who agreed to participate in the study were given "Pregnant Introduction Form", "Labor Monitoring Form", "Visual Analogue Scale (VAS)", "Birth Comfort Scale", "State Anxiety Scale", "Postpartum Evaluation Form" and "Birth Satisfaction Scale". "Short Form (DÖ-SHORT FORM)" forms are filled out. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 717
Key inclusion criteria (9 listed)
- Having a single, live fetus in vertex position
- Being in the latent phase of labor
- Cervical dilation is less than 5 cm
- Planning vaginal birth
- No pregnancy complications
Key exclusion criteria (3 listed)
- Narcotic analgesic or sedative area
- Those with systemic diseases such as heart disease, hypertension, diabetes, kidney disease
- Pregnant women with pregnancy complications (placenta previa, preeclampsia, oligohydramnios, polyhydramnios, position/presentation disorder, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vizüel Analog Skala (VAS)
Time frame: from the 1st stage of labor to birth
The most common VAS consists of a 10 cm horizontal or vertical line with two ends labeled "no pain" and "worst possible pain" (or similar verbal descriptors). Patients are asked to place a mark on a point on a 10 cm line that corresponds to the level of pain intensity they feel. The distance in centimeters from the lower end of the VAS to the mark placed by the patient is used as the numerical value of pain intensity.
Pregnant Introduction Form
Time frame: from the 1st stage of labor to the 2nd hour after birth
By scanning the literature, there are a total of 39 questions: 10 questions covering the sociodemographic characteristics of the pregnant woman, 17 questions covering her medical and obstetric characteristics, and 12 questions covering her knowledge and thoughts about birth.
Labor Follow-up Form
Time frame: from the 1st stage of labor to the 2nd hour after birth
In the labor follow-up form; week of gestation, date and time when labor pains started, medications and applications administered in the first stage of labor, table of evaluations before and after reflexology massage application (cervical dilatation and effacement, head level and condition of membranes, intensity and frequency of contractions, fetal heart rate ( FKA), the mother's vital signs and behaviors during labor), the start time of the 2nd stage, the end time, the total duration of labor, questions regarding the first evaluation of the newborn (baby's gender, head circumference, weight, height, APGAR score and health status, initiation of the first breastfeeding and the mother's breastfeeding status).
Birth Comfort Scale
Time frame: from the 1st stage of labor to the 2nd hour after birth
It consists of questions about pregnant women's opinions about their birth comfort during VM. The Cronbach Alpha coefficient of the scale was found to be 0.75. 24 The Cronbach Alpha coefficient of this study was found to be 0.72. The scale consists of 9 questions and is in the 5-point Likert type (1 = Totally disagree, 2 = Mostly disagree, 3 = Partially agree, 4 = Mostly agree, 5 = Completely agree). It is expected that the items will be answered considering the comfort in the delivery room. Each expression communicates a specific feeling of comfort (relaxation, relief, or superiority) and dimensions (physical, environmental, psychospiritual, or social). A minimum of 9 and a maximum of 45 points are obtained from the scale. It is stated that as the
Postpartum Evaluation Form
Time frame: from the 1st stage of labor to the 2nd hour after birth
Postpartum evaluation form; It was prepared to evaluate the birth process for participants in the DSO group and control group. It is administered at the 2nd hour after birth and includes questions about the pregnant woman's thoughts about this birth, her thoughts about labor pain, how they feel after birth, and their satisfaction with the practices performed during labor.
Birth Satisfaction Scale Short Form
Time frame: from the 1st stage of labor to the 2nd hour after birth
The Short Form of the Childbirth Satisfaction Scale is a 10-question, 5-point Likert-type scale, consisting of 3 sub-dimensions: "quality of care", "stress during labor" and "personal characteristics of the woman". The "quality of care services" sub-dimension is measured with items 3, 5, 6 and 10, the "stress during labor" sub-dimension with items 1, 2, 7 and 9, and the "personal characteristics of the woman" sub-dimension with items 4 and 8. It is scored as "strongly disagree" (0 points), "disagree" (1 point), "undecided" (2 points), "agree" (3 points), and "strongly agree" (4 points). Scores range from 0 to 40 on the scale, and as the score increases, the satisfaction level increases; low satisfaction <13 points, medium satisfaction 14-27 points, and high satisfaction ≥28 points. 6 items in the scale are positive, 4 items are negative, and 4 items (2nd, 4th, 7th, 8th) are scored in reverse. The Cronbach alpha level of the scale was found to be 0.682.
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 1 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision will be made according to the study results.
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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.
nurgül kılıçaslan principal investigator
İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Massage and Labor Pain, run by Atlas 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 3 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 1 Jul 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?
Vizüel Analog Skala (VAS) (time frame: from the 1st stage of labor to birth). The study lists 6 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 1 Jul 2025.