The Effect of Reflexology on Labor
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2018
CompletedFirst Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedMarch 15, 2019
March 1, 2019
1 year
March 4, 2019
March 13, 2019
Conditions
Keywords
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
EXPERIMENTALIn 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.
Control Group
NO INTERVENTIONThe 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
Eligibility Criteria
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Semra Çevik, phD
University of Gaziantep
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- 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