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NCT Number: NCT07045675

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnancy at term (37-42 weeks)

  • 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.

Exclusion criteria

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.).

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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