Effect of Foot Reflexology on Postpartum Afterpains

This study will be conducted to determine the effect of foot reflexology on afterpains after normal labor.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Labor
• Intervention / Treatment: Other: Reflexology; Other: general foot massage; Other: placebo reflexology

Detailed Description

Afterpains are among the most prevalent complaints after natural vaginal delivery. Non-pharmacological treatment modalities to relieve afterpains are an important care priority as they can lead to maternal and neonatal complications including anxiety, sleep disturbances, emotional disorders, depression, inability to care for the baby and continue breastfeeding, delays in early breastfeeding, reduced maternal ability to perform daily chores.

It was reported that pain in the early hours postpartum is one of the most important factors contributing to chronic postpartum pain and depression. Furthermore, pain and stress increase adrenaline release and decrease oxytocin release, thus leading to the cessation of the oxytocin reflex and disrupting breast milk production in addition to causing discomfort for the mother.

Since afterpains is a common problem that affects the physical and mental well-being of mothers, it requires the attention of healthcare providers. There is only one study that investigated the effect of reflexology on the pain level of afterpains after normal vaginal delivery. Moreover, no study investigated the effect of reflexology on either the behavioral response toward pain or the pressure pain threshold. Therefore, this study will be conducted to provide physiotherapists with updated scientific Knowledge concerning the effect of foot reflexology on afterpains after normal labor. This Study may expand the role of physiotherapy in women's health.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hala I Mahmoud, Master; Phone Number: 01116341936; Email: maryamsamma@gmail.com
• Study Contact Backup: Name: Mai Ali, PHD; Phone Number: 01126533836; Email: mai_shehata@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Hala Ismail Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• They will be multipara (2-3).
• They will be normal vaginal labor

Exclusion Criteria:

• High-risk pregnancy.
• Post-partum hemorrhage.
• Neonatal birth weight over 4 kg.
• Over distension of the uterus.
• Cesarean section.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reflexology group; The participants will receive reflexology on foot and on specific uterine points in the first hour post-partum and will be repeated in the second hour post-partum	Other: Reflexology; The participants will receive two minutes of specific reflexology on each point of the uterus, pituitary, and solar plexus in the form of rotational pressures. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum; Other: general foot massage; The participants will receive a general massage on each foot for four minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum
Active Comparator: Placebo reflexology; The participants will receive reflexology on foot and on heel (placebo points) in the first hour post-partum and will be repeated in the second hour post-partum	Other: general foot massage; The participants will receive a general massage on each foot for four minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum; Other: placebo reflexology; The participants will receive rotational pressures on a neutral point on the lateral side of the heel (placebo point) for six minutes. This will be performed in the first hour post-partum and will be repeated in the second hour post-partum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain intensity	It will be used to assess pain levels in women in both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum. It comprises 16 items that reflect equally the sensory (11 items) and affective (5 items) dimensions of pain. These items were responded to by 5 points Likert-like scale as follows: 0 = none, 1= Mild, 2 = Moderate 3 =Severe, 4 = Unbearable pain. The total score will be ranged between 0 to 60 and classified as follows: No pain = 0, mild pain (from 1 to 15), moderate pain (from 16 to 30), severe pain (from 31 to 45), and unbearable pain (from 46 to 60). These pain-rating scales have shown good validity and reliability for assessing pain intensity. The intraclass correlation coefficients were 0.95	4 hours
Modified version of chamber price pain Rating Scale	This tool was adapted for measuring any behavioral responses towards pain including 4 dimensions: Gross motor activity, posture, verbalization, and facial expression. For each dimension, one of 3 alternatives (0, 1, and 2) is to be elicited by the researcher. For posture, the alternatives are very relaxed, guarded, and tense posture. For gross motor activity, the alternatives are very restless, slightly restless, and quiet. For facial expression, alternatives are not frowning, some frowning, and constant frowning or grimacing. Lastly, women's verbalization differs between normal, no sound, groans/moans, and cries/sobs. The total score of the 4 dimensions varies between 0-8 and is categorized as follows: no pain (0) mild pain (1-2), moderate pain (3-4), severe pain (5-6), and intolerable pain (7- 8). it will be measured for both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum.	4 hours
Pressure pain threshold (PPT):	The pressure algometer will be used to measure deep muscular tissue sensitivity for participants in both groups before treatment (1 hour postpartum), after 2 hours, 3 hours and 4 hours postpartum.. The test determines the amount of pressure over a given area in which a steadily increasing no-painful-pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. Six points will be determined to evaluate the PPTs. PPT recording sites will be marked out the abdomen around the umbilical scar and lumbar region as follows: Two measurements 4 cm from the umbilicus, bilaterally (points I and II), two other measurements 4 cm below the previous ones (points III and IV), a single measurement 4 cm from the lower margin of the umbilicus (point V) and another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, correspond-in to S2-S4 (point VI).	4 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Doaa Osman, As professor, Cairo University; Study Director: Hazem El-Ashmawy, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: P.T.REC/012/005673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No