ReflexologyNCT03877302
The Effect of Reflexology on Labor
A study testing reflexology in people with Reflexology, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reflexology
- What is being tested?
- reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 7 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27000
About this study
Official title: The Effect of Reflexology on Labor: A Randomized Controlled Experimental Study
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.
Read the detailed description
Aims:This study was conducted as a randomized controlled experimental study in order to determine the effect of reflexology application in primiparous pregnant women on labor pain, anxiety, labor duration, and birth satisfaction.
METHOD Participants The study was conducted with voluntary pregnant women applying to the delivery room unit of Gaziantep Cengiz Gökçek Maternity and Children Hospital to perform their first birth between 01 July 2017 and 07 July 2018. When the sample volume that would represent the population with the conditions of α= 0.05 risk, 1-α =0.95 accuracy rate, B= 0.20, 1-B= 0.80 power ratio was considered with the comparison results of VAS mean scores in the study by Dolation et al., it was determined to be minimum 27 people for each group.
The study was conducted with two groups including Reflexology Group (experimental) and Control Group. By including 30 women into each group, the study was conducted with a total of 60 women. The drawing method was used to decide to which group the women would be assigned. In order to draw lots, 60 small paper pieces were prepared, control was written on 30 of these paper pieces, reflexology was written on the other 30 pieces of paper, and they were then folded and placed into a bag. Inclusion of women into groups was determined according to the papers women drew from the bag.
Data Collection Tools The data of the study were collected using "Descriptive Information Form", "Visual Analog Scale (VAS)", "State-Trait Anxiety Scale (STAI FORM TX-I )", and "Birth Satisfaction Scale".
Descriptive Information Form: The form prepared by the researcher by examining the related literature consists of two sections. In the first section, age, height, weight, educational level, and working status of the woman along with the number of birth, parity, number of abortus, number of living children, and modes of previous births were asked. The second section of the form includes questions related to the period of birth stages (Stages I, II, and III), interventions made in the first stage of birth and during the labor (Oxytocin administration, amniotomy, Fundal pressure, Vacuum etc.), perineal tear, Apgar score and the newborn's status of being accepted to the intensive care unit.
Visual Analog Scale (VAS): Visual Analogue Scale (VAS) is used to describe the severity of pain in patients with 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.
State-Trait Anxiety Inventory: To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely. The state-trait anxiety inventory requires the individual to describe how he/she feels at a certain moment and under certain conditions by considering his/ her feelings about a specific situation. While high scores indicate high anxiety levels, low scores indicate low anxiety levels. The state-trait anxiety inventory consists of 20 statements. The score obtained from the scale may vary between 20 and 80. While a high score represents a high anxiety level, a low score represents a low anxiety level.
Birth Satisfaction Scale: Birth Satisfaction Scale was developed by Martin and Fleming in 2009. The original language of the scale is English. The translation of the scale was performed by Coşar et al.,. The scale is a Likert-type scale that is scored according to the responses. The scale form consists of 30 items and total score obtained from the scale varies between 30 and 150. As the scores obtained from the scale increase, birth satisfaction level increases.
- Conditions
- Reflexology
- Being tested
- reflexology
- Keywords
- Birth, Reflexology, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexologyOther
foot reflexology
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (1)
State-Trait Anxiety Inventory
The State Anxiety Inventory requires the individual to describe how she feels at a certain moment and under certain conditions by considering her emotions about the situation she is in. While high scores refer to high anxiety levels, low scores indicate low anxiety levels. The state anxiety inventory consists of 20 expressions. The score value obtained from the scale varies between 20 and 80 points. While high score indicates high anxiety level, low score shows low anxiety level. In scoring made according to the criteria directive, 0-19 points are evaluated as "none", 20-39 points as "mild", 40-59 points as "moderate", 60-79 points as "severe", and 80 points as "severe anxiety".The State -Trait Anxiety Inventory (STAI FORM TX-I) was evaluated 2 times as active (4-7 cm) and transition (8-10 cm) phases after reflexology application.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Jul 2017
- Primary completion7 Jul 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReflexologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Çevik, phD, University of Gaziantep
- Investigators
- Semra Çevik, phD, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877302
- Sponsor's protocol ID
- 2017/159
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology on Labor: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT03877302
- Acronym / sponsor ID
- 2017/159
- Conditions
- Reflexology
- Keywords
- Birth, Reflexology, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aims:This study was conducted as a randomized controlled experimental study in order to determine the effect of reflexology application in primiparous pregnant women on labor pain, anxiety, labor duration, and birth satisfaction.
METHOD Participants The study was conducted with voluntary pregnant women applying to the delivery room unit of Gaziantep Cengiz Gökçek Maternity and Children Hospital to perform their first birth between 01 July 2017 and 07 July 2018. When the sample volume that would represent the population with the conditions of α= 0.05 risk, 1-α =0.95 accuracy rate, B= 0.20, 1-B= 0.80 power ratio was considered with the comparison results of VAS mean scores in the study by Dolation et al., it was determined to be minimum 27 people for each group.
The study was conducted with two groups including Reflexology Group (experimental) and Control Group. By including 30 women into each group, the study was conducted with a total of 60 women. The drawing method was used to decide to which group the women would be assigned. In order to draw lots, 60 small paper pieces were prepared, control was written on 30 of these paper pieces, reflexology was written on the other 30 pieces of paper, and they were then folded and placed into a bag. Inclusion of women into groups was determined according to the papers women drew from the bag.
Data Collection Tools The data of the study were collected using "Descriptive Information Form", "Visual Analog Scale (VAS)", "State-Trait Anxiety Scale (STAI FORM TX-I )", and "Birth Satisfaction Scale".
Descriptive Information Form: The form prepared by the researcher by examining the related literature consists of two sections. In the first section, age, height, weight, educational level, and working status of the woman along with the number of birth, parity, number of abortus, number of living children, and modes of previous births were asked. The second section of the form includes questions related to the period of birth stages (Stages I, II, and III), interventions made in the first stage of birth and during the labor (Oxytocin administration, amniotomy, Fundal pressure, Vacuum etc.), perineal tear, Apgar score and the newborn's status of being accepted to the intensive care unit.
Visual Analog Scale (VAS): Visual Analogue Scale (VAS) is used to describe the severity of pain in patients with 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.
State-Trait Anxiety Inventory: To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely. The state-trait anxiety inventory requires the individual to describe how he/she feels at a certain moment and under certain conditions by considering his/ her feelings about a specific situation. While high scores indicate high anxiety levels, low scores indicate low anxiety levels. The state-trait anxiety inventory consists of 20 statements. The score obtained from the scale may vary between 20 and 80. While a high score represents a high anxiety level, a low score represents a low anxiety level.
Birth Satisfaction Scale: Birth Satisfaction Scale was developed by Martin and Fleming in 2009. The original language of the scale is English. The translation of the scale was performed by Coşar et al.,. The scale is a Likert-type scale that is scored according to the responses. The scale form consists of 30 items and total score obtained from the scale varies between 30 and 150. As the scores obtained from the scale increase, birth satisfaction level increases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| reflexology group | Experimental | Other: reflexologyIn 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 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflexologyfoot reflexology | Other | reflexology group |
Primary outcome
VAS scores
Time frame: 6 hours
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.
1 secondary outcome
State-Trait Anxiety Inventory
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semra Çevik, phD principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology in people with Reflexology, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scores (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.