NCT03877302

Brief Summary

Aims and Objectives: The purpose of this study was to determine the effect of reflexology, one of the non-pharmacological methods used in the management of labor pain, on anxiety, labor duration, labor pain, and labor satisfaction in primiparous pregnant women. Background: Labor pain is one of the most severe types of pain experienced by a woman throughout her life. As a result of the labor pain and birth-related stress, maternal and fetus health is negatively affected. Controlling of labor pain will decrease the anxiety and tension experienced by pregnant woman. Design: A randomized controlled experimental was used. Method: A total of 60 women participated in the study in 2 groups of 30 for reflexology and control groups. By giving appropriate position in the first stage of delivery to the pregnant women in the experimental group, 10-minute massage was applied to both feet including 5-minute massage for each foot starting first from the right foot by using vaseline under the supervision of a doctor to facilitate the hand movements, then the reflexology technique was applied by stimulating the nerve points by applying pressure to reflex regions of each foot for 20 minutes as totally 40 minutes for both feet. The control group was composed of pregnant women who received routine treatment, care and applications of the hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 4, 2019

Last Update Submit

March 13, 2019

Conditions

Keywords

BirthReflexologyPain

Outcome Measures

Primary Outcomes (1)

  • VAS scores

    Visual Analogue Scale (VAS) was used to measure the severity of labour pain. The diagnosis will be established based on subjective data including the patient's verbal expression. There are numbers horizontally placed varying from 0 to 10. The pain severity is expressed in numbers ranging from 0 to 10 and no pain is determined with "0" and the most severe pain is determined with "10". In this method, it is explained that there are two endpoints and she is free to mark any point between these two points Analog Scale (VAS) was evaluated 2 times as active (4-7 cm) and transition (8-10 cm) phases after reflexology application.

    6 hours

Secondary Outcomes (1)

  • State-Trait Anxiety Inventory

    6 hours

Other Outcomes (1)

  • Birth Satisfaction

    1 hour

Study Arms (2)

reflexology group

EXPERIMENTAL

In addition to providing routine nursing/midwifery care, foot reflexology was applied by the researcher to the pregnant women in the experimental group in the active phase of labor (dilatation 4 cm). By giving appropriate position to the pregnant women, the massage was done to both feet for totally 10 minutes including 5 minutes for each foot starting from right foot under the supervision of a doctor. Whereupon, the reflexology technique was applied by stimulating the nerve points by applying pressure to reflex regions of each foot for 20 minutes as totally 40 minutes for both feet. As reflex points of the feet for manual pressure in labor pain; 1: Solar Plexus, 2: Hypothalamus, 3: Pituitary, 4: Spleen, 5: Thyroid Gland, 6: Adrenal, 7: Intestine, 8: Spinal Cord 9: Uterus, Vagina, Ovaries and Fallopian Tubes were studied.

Other: reflexology

Control Group

NO INTERVENTION

The control group received only routine treatment, care, and practices of the hospital. Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI FORM TX-I) were evaluated 2 times as in active (4-7 cm) and transition (8-10 cm) phases in the pregnant women in the control group. After the delivery, the Birth Satisfaction Scale was applied to the women by the researcher.

Interventions

foot reflexology

reflexology group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who were 19 years old and older,
  • Pregnant women who had singleton pregnancy, were between 38-42nd weeks of gestation,
  • Pregnant women who can perform spontaneous vaginal delivery,
  • Pregnant women who were at the beginning of the active phase in the first phase of action (4 cm dilatation),
  • Pregnant women who were primiparous, can establish verbal communication,
  • Pregnant women who agreed to participate in the study.

You may not qualify if:

  • Pregnant women who had risky pregnancy,
  • Pregnant women who had a systemic disease that would interfere with normal birth,
  • Pregnant women who were in the second stage of labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Şehitkamil, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Semra Çevik, phD

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A total of 60 women participated in the study in 2 groups of 30 for reflexology and control groups. By giving appropriate position in the first stage of delivery to the pregnant women in the experimental group, 10-minute massage was applied to both feet including 5-minute massage for each foot starting first from the right foot by using vaseline under the supervision of a doctor to facilitate the hand movements, then the reflexology technique was applied by stimulating the nerve points by applying pressure to reflex regions of each foot for 20 minutes as totally 40 minutes for both feet. The control group was composed of pregnant women who received routine treatment, care and applications of the hospital.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiatant Professor

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 15, 2019

Study Start

July 1, 2017

Primary Completion

July 7, 2018

Study Completion

July 7, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations