The Effect of Foot Reflexology Massage on the Perception of Labor Pain in Nulliparous Pregnant Women

NCT07045675 | Active Not Recruiting

• 1 other identifier: AU-EY-NK-01
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Massage; Labor Pain; Foot Massage; Refleksoloji

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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).

  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

  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.

  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.

  from the 1st stage of labor to the 2nd hour after birth

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: nulliparous pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

717

You may qualify if:

• 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
• No language problems
• Able to communicate verbally
• Pregnant women who agree to work.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, Istanbul, 34303, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• nurgül kılıçaslan

  İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mide wife

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: July 1, 2025
• Study Start: January 30, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

TU (1)