MidwiferyNCT05734885
The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process
A study testing Back and Sacral massage massage application in people with Midwifery and Labor Delivery, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
H1-1 = There will be a difference between the pain levels of the partner massage group, midwife massage group, and control group following the massage application. H1-2 = There will be a difference between the state anxiety levels of the partner massage group, midwife massage group, and control group following the… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midwifery, Labor Delivery, Massage
- What is being tested?
- Back and Sacral massage massage application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Aug 2023
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those aged 20-35
- Term pregnancies (those at 37-41 weeks of gestation)
- Those with a single fetus
- Primiparous
- Those who do not have any risk factors during pregnancy (Preeclampsia, premature rupture of membranes, placental anomalies, macrosomic baby, etc.)
- Those who do not have any chronic disease
Show all 12Show fewer
- Pregnant women who do not have skin disease, infection or varicose affecting the massage application.
- Pregnant women with no deterioration in skin integrity
- Those with cervical dilatation less than 4 cm
- Those who are open to communication, mentally and mentally healthy
- Those who agreed to participate in the study
- Pregnant women with a spouse who agree to apply and apply massage for the spouse/partner massage group.
Who cannot join
- Those who are in the active and transitional phase of labor
- Abnormal changes in fetal heartbeats
- Unexpected complication in pregnancy and fetus
- Pregnant women who use pharmacological methods to reduce pain during labor
- Pregnant women with contraindications for massage application (deterioration of skin integrity, varicose veins, skin disease and infection)
- Pregnant women who are reluctant to continue participating in the research
Trial locations and contacts
1 site in 1 country.
About this study
H1-1 = There will be a difference between the pain levels of the partner massage group, midwife massage group, and control group following the massage application.
H1-2 = There will be a difference between the state anxiety levels of the partner massage group, midwife massage group, and control group following the massage application.
H1-3 = There will be a difference between the active phase durations of the partner massage group, midwife massage group, and control group following the massage application.
Read the detailed description
Supporting the woman with massage during the labor process reduces the severity of pain, provides general relaxation and reduces anxiety. The application of spousal massage for supportive care to the woman during the labor process can provide important positive results in terms of providing both physical and emotional support. A positive perception of birth can be strengthened by meeting women's needs at a higher level. This may contribute to effective pain management, reduction of anxiety in women, improvement of birth outcomes and positive neonatal health outcomes. When the literature is examined, it has been determined that the scope and number of studies examining the effect of partner massage in labor on pain, anxiety and birth process is very limited, and there is no study on the subject in the national literature.
- Conditions
- Midwifery, Labor Delivery, Massage
- Being tested
- Back and Sacral massage massage application
- Keywords
- Labor, massage, partner massage, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back and Sacral massage massage applicationOther
Massage will be applied to the pregnant woman in the position preferred by the pregnant woman. Circular movements are applied to the sacrum with the thumb. Pressure is applied to both sides of the spinal cord with the thumb. The thumb is moved towards the hip of the pregnant woman at 1.5 cm intervals, starting from the lower part of the pelvis and the sacrum. The palm is placed in direct contact with the mother's sacrum and pressure is applıed. The massage is completed by making a bunch of flowers from the sacrum upwards, towards the shoulder and around it.
| Study group | Role | What they receive |
|---|---|---|
| Midwife Massage Experimental Group (1) | Experimental | Back and sacral massage will be applied to pregnant women in labor in the application group. Massage will be applied by the research midwife. Midwife massage will be performed when cervical dilation is 5-6 cm and 8-9 cm.
Massage application time will last 20 minutes. Receives: Other: Back and Sacral massage massage application |
| Spouse Massage Experimental Group (2) | Experimental | Back and sacral massage will be applied to pregnant women in labor in the application group. Massage will be applied by the spouse of the pregnant woman. Massage will be performed when cervical dilation is 5-6 cm and 8-9 cm.
Massage application time will last 20 minutes. Receives: Other: Back and Sacral massage massage application |
| Control Group | No intervention | It will be perform routine practice who the women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnant Introduction Form
The pregnancy information form, which was prepared by the researcher following a literature review, consisted of 18 questions about some socio-demographic characteristics of pregnant women (age, education level, social security status, etc.) and their obstetric characteristics (gestational week, problems during pregnancy, etc.),
Measured: in active phase on labor (4 cm and less vaginal dilatation)
Labor Monitoring Form
This form was developed by the researcher following a literature review. It consisted of five items about the practices applied to pregnant women during labor (interventions applied during labor (forceps, vacuum, etc.)) and the characteristics of the newborn in the postpartum period (Apgar score, newborn weight, etc.),
Measured: in labor and in the first 24 hours postpartum
Partograph
This is a tool used to assess the progress of labor and the health status of the fetus. It is used from the active phase of labor. It visualizes the progress of labor; cervical dilatation, the level of the fetal head, the frequency and duration of uterine contractions, fetal heart rate, the presence of amniotic membrane, and the color of amniotic fluid are evaluated and recorded on a graph paper Its central feature is a graph used to record the progress of cervical dilation, as determined by vaginal examination.
Indicators are plotted on the graph each time they are checked:
- Maternal indicators:
- Time of spontaneous or artificial rupture of the membranes
- Uterine contractions (number per 10 minutes and duration)
- Drugs administered (oxytocin, antibiotics, etc.)
- Foetal indicators:
- Foetal heart rate
- Amniotic fluid (colour, odour and quantity)
- Descent of the foetal head and head moulding
Measured: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
Visual Analog Skala-VAS
The VAS was first developed by Price et al. (1983). The VAS is used to measure perceived pain. 10 cm, which says painlessness at one end and the most severe pain at the other end. On a (100 mm.) ruler, the patient describes his or her pain by drawing a line, pointing, or pointing. The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain.
Measured: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
Spielberger State Anxiety Scale
It was developed by Spielberg et al in 1970. It was adapted into Turkish by Öner and Le Compte in 1983 (Öner \& Le Compte, 1983; Özusta, 1995). The state anxiety scale is a scale that determines how an individual feels at a particular moment and situation. It requires the individual to answer the feelings or behaviors he/she experiences in his/her situation by marking one of the options such as (1) Not at all, (2) A little, (3) A lot and (4) Completely. The state anxiety scale consists of 20 statements. The score obtained from the scale can vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. In the scoring made in accordance with the criteria directive, 0-19 points are evaluated as "absent", 20-39 points as "mild", 40-59 points as "moderate", 60-79 points as "severe" and 80 points as severe anxiety (Dönmez, Yeniel, \& Kavlak, 2014).
Measured: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
Assessment of Satisfaction Scale
This scale was adopted by the researcher from the "Visual Analog Scale (VAS)", which individuals can easily understand [35]. The VAS helps measure some variables numerically, which is not possible otherwise. This scale was used to evaluate the satisfaction of the women in the study group with the massage application and the labor process. The numbers between 0 and 10, which were intended to indicate the point corresponding to the satisfaction status, were placed on a vertical line. A score of 0 on the scale indicated "not satisfied at all", while a score of 10 indicated "very satisfied."
Measured: in the first 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MidwiferyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size of the study was calculated based on the results of a study aiming to determine the effect of birth dance applied with the support of a spouse and midwife during labor on birth pain and satisfaction \[19\]. It was found as 116 participants, including 39 in each group, on the G\*power 3.1.9.2 (Ver. 3.1.9.2) \[20\] software, based on an effect size of 0.71, a power of 0.95, and an alpha level of 0.05. Considering some attrition, an additional 15% was added to the sample size, and the study was planned to be conducted with 141 women (47 in the partner massage group, 47 in the midwife massage group, and 47 in the control group). During monitoring, two participants were lost from each group. Eventually, the study was completed with a total of 135 women, 45 in each group.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Nur Atas, Selcuk University
- Investigators
- Ayşe Nur Ataş, Principal investigator, Necmettin Erbakan University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734885
- Sponsor's protocol ID
- 0000-0003-3096-3599
- Status last verified
- Dec 2024
- First submitted
- 8 Feb 2023
- Last updated
- 5 Dec 2024
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process
- ClinicalTrials.gov ID
- NCT05734885
- Acronym / sponsor ID
- 0000-0003-3096-3599
- Conditions
- Midwifery, Labor Delivery, Massage
- Keywords
- Labor, massage, partner massage, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 21 Feb 2023 (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.
H1-1 = There will be a difference between the pain levels of the partner massage group, midwife massage group, and control group following the massage application.
H1-2 = There will be a difference between the state anxiety levels of the partner massage group, midwife massage group, and control group following the massage application.
H1-3 = There will be a difference between the active phase durations of the partner massage group, midwife massage group, and control group following the massage application.
Detailed description
Supporting the woman with massage during the labor process reduces the severity of pain, provides general relaxation and reduces anxiety. The application of spousal massage for supportive care to the woman during the labor process can provide important positive results in terms of providing both physical and emotional support. A positive perception of birth can be strengthened by meeting women's needs at a higher level. This may contribute to effective pain management, reduction of anxiety in women, improvement of birth outcomes and positive neonatal health outcomes. When the literature is examined, it has been determined that the scope and number of studies examining the effect of partner massage in labor on pain, anxiety and birth process is very limited, and there is no study on the subject in the national literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The sample size of the study was calculated based on the results of a study aiming to determine the effect of birth dance applied with the support of a spouse and midwife during labor on birth pain and satisfaction [19]. It was found as 116 participants, including 39 in each group, on the G*power 3.1.9.2 (Ver. 3.1.9.2) [20] software, based on an effect size of 0.71, a power of 0.95, and an alpha level of 0.05. Considering some attrition, an additional 15% was added to the sample size, and the study was planned to be conducted with 141 women (47 in the partner massage group, 47 in the midwife massage group, and 47 in the control group). During monitoring, two participants were lost from each group. Eventually, the study was completed with a total of 135 women, 45 in each group.
| Arm | Type | Receives |
|---|---|---|
| Midwife Massage Experimental Group (1) | Experimental | Other: Back and Sacral massage massage applicationBack and sacral massage will be applied to pregnant women in labor in the application group. Massage will be applied by the research midwife. Midwife massage will be performed when cervical dilation is 5-6 cm and 8-9 cm. Massage application time will last 20 minutes. |
| Spouse Massage Experimental Group (2) | Experimental | Other: Back and Sacral massage massage applicationBack and sacral massage will be applied to pregnant women in labor in the application group. Massage will be applied by the spouse of the pregnant woman. Massage will be performed when cervical dilation is 5-6 cm and 8-9 cm. Massage application time will last 20 minutes. |
| Control Group | No intervention | –It will be perform routine practice who the women in the control group. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Those aged 20-35
- Term pregnancies (those at 37-41 weeks of gestation)
- Those with a single fetus
- Primiparous
- Those who do not have any risk factors during pregnancy (Preeclampsia, premature rupture of membranes, placental anomalies, macrosomic baby, etc.)
Key exclusion criteria (6 listed)
- Those who are in the active and transitional phase of labor
- Abnormal changes in fetal heartbeats
- Unexpected complication in pregnancy and fetus
- Pregnant women who use pharmacological methods to reduce pain during labor
- Pregnant women with contraindications for massage application (deterioration of skin integrity, varicose veins, skin disease and infection)
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 |
|---|---|---|
| Back and Sacral massage massage applicationMassage will be applied to the pregnant woman in the position preferred by the pregnant woman. Circular movements are applied to the sacrum with the thumb. Pressure is applied to both sides of the spinal cord with the thumb. The thumb is moved towards the hip of the pregnant woman at 1.5 cm intervals, starting from the lower part of the pelvis and the sacrum. The palm is placed in direct contact with the mother's sacrum and pressure is applıed. The massage is completed by making a bunch of flowers from the sacrum upwards, towards the shoulder and around it. | Other | Midwife Massage Experimental Group (1), Spouse Massage Experimental Group (2) |
Primary outcome
Pregnant Introduction Form
Time frame: in active phase on labor (4 cm and less vaginal dilatation)
The pregnancy information form, which was prepared by the researcher following a literature review, consisted of 18 questions about some socio-demographic characteristics of pregnant women (age, education level, social security status, etc.) and their obstetric characteristics (gestational week, problems during pregnancy, etc.),
Labor Monitoring Form
Time frame: in labor and in the first 24 hours postpartum
This form was developed by the researcher following a literature review. It consisted of five items about the practices applied to pregnant women during labor (interventions applied during labor (forceps, vacuum, etc.)) and the characteristics of the newborn in the postpartum period (Apgar score, newborn weight, etc.),
Partograph
Time frame: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
This is a tool used to assess the progress of labor and the health status of the fetus. It is used from the active phase of labor. It visualizes the progress of labor; cervical dilatation, the level of the fetal head, the frequency and duration of uterine contractions, fetal heart rate, the presence of amniotic membrane, and the color of amniotic fluid are evaluated and recorded on a graph paper Its central feature is a graph used to record the progress of cervical dilation, as determined by vaginal examination. Indicators are plotted on the graph each time they are checked: * Maternal indicators: * Time of spontaneous or artificial rupture of the membranes * Uterine contractions (number per 10 minutes and duration) * Drugs administered (oxytocin, antibiotics, etc.) * Foetal indicators: * Foetal heart rate * Amniotic fluid (colour, odour and quantity) * Descent of the foetal head and head moulding
Visual Analog Skala-VAS
Time frame: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
The VAS was first developed by Price et al. (1983). The VAS is used to measure perceived pain. 10 cm, which says painlessness at one end and the most severe pain at the other end. On a (100 mm.) ruler, the patient describes his or her pain by drawing a line, pointing, or pointing. The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain.
Spielberger State Anxiety Scale
Time frame: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
It was developed by Spielberg et al in 1970. It was adapted into Turkish by Öner and Le Compte in 1983 (Öner \& Le Compte, 1983; Özusta, 1995). The state anxiety scale is a scale that determines how an individual feels at a particular moment and situation. It requires the individual to answer the feelings or behaviors he/she experiences in his/her situation by marking one of the options such as (1) Not at all, (2) A little, (3) A lot and (4) Completely. The state anxiety scale consists of 20 statements. The score obtained from the scale can vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. In the scoring made in accordance with the criteria directive, 0-19 points are evaluated as "absent", 20-39 points as "mild", 40-59 points as "moderate", 60-79 points as "severe" and 80 points as severe anxiety (Dönmez, Yeniel, \& Kavlak, 2014).
Assessment of Satisfaction Scale
Time frame: in the first 24 hours postpartum
This scale was adopted by the researcher from the "Visual Analog Scale (VAS)", which individuals can easily understand [35]. The VAS helps measure some variables numerically, which is not possible otherwise. This scale was used to evaluate the satisfaction of the women in the study group with the massage application and the labor process. The numbers between 0 and 10, which were intended to indicate the point corresponding to the satisfaction status, were placed on a vertical line. A score of 0 on the scale indicated "not satisfied at all", while a score of 10 indicated "very satisfied."
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 5 Dec 2024.
- 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.
Ayşe Nur Ataş principal investigator
Necmettin Erbakan University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back and Sacral massage massage application in people with Midwifery and Labor Delivery, 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 12 inclusion and 6 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 5 Dec 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?
Pregnant Introduction Form (time frame: in active phase on labor (4 cm and less vaginal dilatation)). The study lists 6 primary outcomes in all. 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 5 Dec 2024.