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Completed

NCT Number: NCT04037202

Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth

Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.

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Key information

Conditions

Postpartum Disorder Agnosia Female Urogenital Diseases and Pregnancy Complications Massage Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

Background and purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.

Materials and methods: In order to keep the number of people in balance between the groups, "block randomization" method which is one of the fixed probability randomization types was preferred. The research was completed with 66 persons, 33 in the study group and 33 in the control group. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.

Research inclusion criteria include (i) primipara mothers (who had their first birth), (ii) mothers who had normal vaginal delivery, (iii) those who had undergone episiotomy, (iv) who were volunteered to participate in the study, (v) who were on the first day of delivery (first 24 hours), (vi) who had no complications in the infant and the baby, (vii) age of whom ranged from 18 to 35, (viii) those who did not apply or receive any other complementary therapy, (ix) mothers who did not have any wound, infection or discomfort etc. on their feet, and those who can read and write.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • primipara mothers (who had their first birth),
  • mothers who had normal vaginal delivery,
  • those who had undergone episiotomy,
  • who were volunteered to participate in the study,
  • who were on the first day of delivery (first 24 hours),
  • who had no complications in the infant and the baby,
  • age of whom ranged from 18 to 35,
  • those who did not apply or receive any other complementary therapy,
  • mothers who did not have any wound, infection or discomfort etc. on their feet,
  • mothers who can read and write

Exclusion criteria

  • mothers with any systemic disease
  • mothers who dislike foot massage during practice
  • early discharge mothers
  • mothers who applied another massage technique
  • mothers who take the analgesic drug unnecessarily

Treatment and study plan

foot massage

Other

Foot massage includes classical massage techniques such as effleurage, petrissage and friction techniques. Effleurage is the movement of stroking and lubricating superficial tissues. Therefore, it is performed at the beginning and ending of the massage. Petrissage is the slow and rhythmic movement to apply direct pressure to the soft tissue underlying the skin with the balls of the fingers and thumbs. Friction is the application of pressure through small circular movements only in small areas, using hand or fingers. While muscle tissue is compressed and relaxed, blood and lymph circulation increases. Thus, lactic acid in the muscle fibers is diminished and fatigue and stress are decreased.

Primary outcomes

  1. Informed Consent Form

    Time frame: 5-10 minutes

    The form consists of 31 questions about family, pregnancy, birth and newborn characteristics.This form was completed during the first meeting at the hospital.

  2. Postpartum Comfort Scale (PCS)

    Time frame: 5-10 minutes

    In accordance with the comfort theory developed by Katharine Kolcaba in 1994, the PCS developed by Karakaplan and Yıldız (2010) consists of 34 items.A 5-point Likert-type scoring system was used to evaluate each item.Expression and scoring were made for each item ranging from "totally agree" (5 points), and "strongly disagree" (1 points).In positive sentences, "I fully agree" indicates the best comfort (5 points) and in negative sentences low comfort (1 points).Accordingly, the lowest score to be taken from the scale is 34 and the highest score is 170.

  3. Visual Analog Scale (VAS)

    Time frame: Less than 1 minute

    It is a single-item continuous scale consisting of a horizontal or vertical line and is usually 10 centimeters (100 mm) in length. For example, the severity of pain a patient feels ranges from "no pain" with 0 points on a line to "severe pain" with 10 points.Scoring is achieved by measuring the point the patient has marked with a ruler.Pain relief points in VAS;

    • Absence of pain (0-4 mm),
    • Slight pain (5-44 mm),
    • Moderate pain (45-74 mm)
    • Severe pain (75-100 mm)

  4. Drug Follow-up Card (DFC)

    Time frame: About 1 minute

    The researcher was prepared, this is a follow-up card in which the name and surname of the mothers, the name of the drug given to the mothers, the route of administration of the drug, date / time and dosage are indicated.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 30, 2019
Registry last updated
Jul 30, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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