Effect of Foot Reflexology on Postpartum Afterpains

NCT06951750 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005673
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Labor

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Reflexology group

EXPERIMENTAL

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; Other: general foot massage

Placebo reflexology

ACTIVE COMPARATOR

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: placebo reflexology; Other: general foot massage

Interventions

Reflexology OTHER

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

Reflexology group

placebo reflexology OTHER

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

Placebo reflexology

general foot massage OTHER

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

Placebo reflexology; Reflexology group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hala Ismail Mahmoud

Cairo, Egypt

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hazem El-Ashmawy, Professor

  Cairo University

  STUDY DIRECTOR

• Doaa Osman, As professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Hala I Mahmoud, Master

CONTACT

01116341936; maryamsamma@gmail.com

Mai Ali, PHD

CONTACT

01126533836; mai_shehata@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: April 30, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 15, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

EG (1)