ParturitionNCT06380400
The Effect of Foot Bath on Birth Pain and Birth Comfort
A study testing Foot bath in people with Parturition, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturition
- What is being tested?
- Foot bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Jul 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primipar pregnancy
- 37 and 42 weeks
- Cervical dilation at least 4 cm
- Head presentation
- Over 18 years of age
- Pregnant women who agreed to participate after being informed about the study
Who cannot join
- People with communication difficulties and mental disabilities
- Any risk condition related to pregnancy (pre-eclampsia, gestational diabetes, anomalies of presentation, anomalies related to the placenta)
- Development of maternal-fetal complications
- Use of anticoagulant therapy
- Pregnant women with a diagnosed psychiatric illness will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Bath on Birth Pain and Birth Comfort in the First Stage of Labour
Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women.
Read the detailed description
The purpose of the study will be explained to pregnant women found to meet the inclusion criteria, and written informed consent will be obtained from participants who volunteer for the study. Participants will be randomly divided into two groups (group 1: intervention group, group 2: control group). Pregnant women will be allocated to the intervention and control groups according to the randomisation scheme to be generated from the random.org website. The personal information form will be used for both intervention and control groups.
Intervention group Pregnant women in the intervention group will receive footbaths for 20 minutes during the active phase of the first stage of labour (after 4 cm cervical dilation) and 20 minutes during the transitional phase of the second stage of labour (9 cm cervical dilation). Pregnant women who completed two footbath sessions were assessed for pain using the visual comparison scale. In addition, the data collection process will be completed by applying the birth comfort scale after two stages of labour.
Control group The process of applying the data collection tools to the pregnant women in the control group is the same as for the intervention group. The pregnant women in the control group will be subjected to the routine practices of the hospital without foot bathing.
Warm water foot bath:
The warm water footbath is performed in 4 steps. Before starting the treatment, warm water is poured into the bucket in which the footbath will take place and the water temperature is set at 41-42°C using a thermometer. In the first stage of the application, the room temperature is between 22 and 25°C. In the second stage, the applicants are made to sit in a chair or armchair. In the third stage, they are allowed to dip their feet into the warm water footbath bucket, where the water temperature is kept between 41 and 42°C, up to the level of the ankles. They are asked to remain in this position for 20 minutes. The temperature of the water is checked between applications and hot water is added when the water cools down. At the end of the treatment, the feet are taken out of the water and dried with a towel. The towel should be left on for 5-7 minutes to allow the heat to work for a while.
- Conditions
- Parturition
- Being tested
- Foot bath
- Keywords
- Birth, Labour, Footbath, Birth pain, Birth comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot bathBehavioural
Pregnant women were given footbaths for 20 minutes during the active phase of the first stage of labour (after cervical dilatation of 4 cm) and 20 minutes during the transitional phase of the second stage of labour (cervical dilatation of 9 cm). Pregnant women who completed two footbath sessions were assessed for pain using the visual comparison scale. In addition, the data collection process will be completed by applying the Birth Comfort Scale after the two stages of labour.
| Study group | Role | What they receive |
|---|---|---|
| Foot bath intervention group | Experimental | Pregnant women are given a foot bath during the first stage of labour. Receives: Behavioral: Foot bath |
| Routine midwifery care control group | No intervention | Pregnant women receive routine midwifery care during the first stage of labour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuell analog scale score of the pregnant woman
Pain levels of pregnant women will be assessed. On one side of the scale there is a line labelled 'no pain' and on the other side there is a line labelled 'severe pain' and on the side immediately behind this line there is a scale divided into 10 equal intervals. The higher the score, the greater the intensity of the pain.
Measured: within the first 24 hours after the time of the birth of the baby
Secondary outcomes (1)
Birth comfort scale score of the pregnant woman
Pregnant women's comfort during childbirth will be assessed. The minimum score that can be obtained from the scale is 14 and the maximum score is 70. The higher the score, the higher the level of comfort.
Measured: within the first 24 hours after the time of the birth of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Feb 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe BAY, Selcuk University
- Investigators
- Habibe Bay Ozcalik, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380400
- Sponsor's protocol ID
- 0000-0001-5786-4385
- Status last verified
- Nov 2024
- First submitted
- 3 Apr 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' information will not be shared with third parties. Research results will be shared with other researchers after the study is completed
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Bath on Birth Pain and Birth Comfort in the First Stage of Labour
- ClinicalTrials.gov ID
- NCT06380400
- Acronym / sponsor ID
- 0000-0001-5786-4385
- Conditions
- Parturition
- Keywords
- Birth, Labour, Footbath, Birth pain, Birth comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Apr 2024 (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.
Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women.
Detailed description
The purpose of the study will be explained to pregnant women found to meet the inclusion criteria, and written informed consent will be obtained from participants who volunteer for the study. Participants will be randomly divided into two groups (group 1: intervention group, group 2: control group). Pregnant women will be allocated to the intervention and control groups according to the randomisation scheme to be generated from the random.org website. The personal information form will be used for both intervention and control groups.
Intervention group Pregnant women in the intervention group will receive footbaths for 20 minutes during the active phase of the first stage of labour (after 4 cm cervical dilation) and 20 minutes during the transitional phase of the second stage of labour (9 cm cervical dilation). Pregnant women who completed two footbath sessions were assessed for pain using the visual comparison scale. In addition, the data collection process will be completed by applying the birth comfort scale after two stages of labour.
Control group The process of applying the data collection tools to the pregnant women in the control group is the same as for the intervention group. The pregnant women in the control group will be subjected to the routine practices of the hospital without foot bathing.
Warm water foot bath:
The warm water footbath is performed in 4 steps. Before starting the treatment, warm water is poured into the bucket in which the footbath will take place and the water temperature is set at 41-42°C using a thermometer. In the first stage of the application, the room temperature is between 22 and 25°C. In the second stage, the applicants are made to sit in a chair or armchair. In the third stage, they are allowed to dip their feet into the warm water footbath bucket, where the water temperature is kept between 41 and 42°C, up to the level of the ankles. They are asked to remain in this position for 20 minutes. The temperature of the water is checked between applications and hot water is added when the water cools down. At the end of the treatment, the feet are taken out of the water and dried with a towel. The towel should be left on for 5-7 minutes to allow the heat to work for a while.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot bath intervention group | Experimental | Behavioral: Foot bathPregnant women are given a foot bath during the first stage of labour. |
| Routine midwifery care control group | No intervention | –Pregnant women receive routine midwifery care during the first stage of labour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primipar pregnancy
- 37 and 42 weeks
- Cervical dilation at least 4 cm
- Head presentation
- Over 18 years of age
Key exclusion criteria (5 listed)
- People with communication difficulties and mental disabilities
- Any risk condition related to pregnancy (pre-eclampsia, gestational diabetes, anomalies of presentation, anomalies related to the placenta)
- Development of maternal-fetal complications
- Use of anticoagulant therapy
- Pregnant women with a diagnosed psychiatric illness will be excluded from the study.
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 |
|---|---|---|
| Foot bathPregnant women were given footbaths for 20 minutes during the active phase of the first stage of labour (after cervical dilatation of 4 cm) and 20 minutes during the transitional phase of the second stage of labour (cervical dilatation of 9 cm). Pregnant women who completed two footbath sessions were assessed for pain using the visual comparison scale. In addition, the data collection process will be completed by applying the Birth Comfort Scale after the two stages of labour. | Behavioural | Foot bath intervention group |
Primary outcome
Visuell analog scale score of the pregnant woman
Time frame: within the first 24 hours after the time of the birth of the baby
Pain levels of pregnant women will be assessed. On one side of the scale there is a line labelled 'no pain' and on the other side there is a line labelled 'severe pain' and on the side immediately behind this line there is a scale divided into 10 equal intervals. The higher the score, the greater the intensity of the pain.
1 secondary outcome
Birth comfort scale score of the pregnant woman
Time frame: within the first 24 hours after the time of the birth of the baby
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 Nov 2024.
- Individual participant dataSharing planned: No. Participants' information will not be shared with third parties. Research results will be shared with other researchers after the study is completed
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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.
Habibe Bay Ozcalik principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot bath in people with Parturition, run by Selcuk University 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 5 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 Nov 2024. 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?
Visuell analog scale score of the pregnant woman (time frame: within the first 24 hours after the time of the birth of the baby). 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 Nov 2024.