MassageNCT05237765
The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
A study of Massage, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to determine the effect of controlled massage applied at birth on labor pain and duration and maternal satisfaction. The study was conducted as a randomized, controlled research. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 29 Dec 2020
- 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 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having at least a primary school degree
- Not having a communication problem
- Having a primiparous term pregnancy (38-42 weeks)
- Not having an obstetric risk
- Being in the latent phase of labor (dilation 0-3cm)
- Having no contraindications for massage
Who cannot join
- Being multiparous
- Having a high-risk pregnancy
- Being in the active or transitional phase of labor
- Having a contraindication to massage
Trial locations and contacts
1 site in 1 country.
About this study
This study was carried out to determine the effect of controlled massage applied at birth on labor pain and duration and maternal satisfaction. The study was conducted as a randomized, controlled research. The research was conducted with 154 randomized pregnant women admitted to Erzurum Nenehatun Obstetrics and Maternity hospital between February-November 2019. The study consisted of 3 different groups: Group A included the pregnant women who received routine hospital care (control group n=53), Group B included the pregnant women who received midwife-controlled massage (n=50), and the Group C consisted of the pregnant women who received self-controlled massage (n=51). It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.
Read the detailed description
This study was conducted to determine the effects of controlled massage applied during labor on pain during labor, labor duration and maternal satisfaction. This was a randomized-controlled experimental study.The study was carried out with the participation of 154 randomly selected pregnant women at an Obstetrics and Gynecology Hospital located in a province in the Eastern Anatolia Region of Turkey between February and November 2019.The study included three groups (A: control group, B: midwife-controlled massage group, C: self-controlled massage group). The data were collected using a "Personal Information Form", the "Visual Analogue Scale (VAS)", the "Verbal Category Scale (VCS)", a "Partograph", an "Individual-Controlled Massage Follow-Up Form" and the "Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)".It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.
IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some nonpharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.
What the results of this study add? There is no studies using thecontrolled massage. In our study, it was found that controlled massage is effective on labor birth.
What the implications are of these findings for clinical practice and/or further research? Our study suggested that midwives and pregnant women could practice controlled massage to reduce labor pain.
- Conditions
- Massage
- Being tested
- controlled (automatic) massage
- Keywords
- Birth, labor duration, labor pain, massage, satisfaction
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled (automatic) massageOther
Massage methods that are performed with mechanical methods are called automated massage. Automated massage is also individual-controlled massage. This is because in automated massage, to relax, solve or reduce their pain, the individual applies the massage under their own control or under the control of someone else through a controller in a way where the duration and intensity of the massage in the body part of application vary. Individual-controlled massage devices may be in the form of chairs, cushions, beds and mattresses. These massage devices have functions such as vibrating, applying vacuum, imitating manual massage motions and applying heat.
| Study group | Role | What they receive |
|---|---|---|
| midwife-controlled massage | Experimental | Not described Receives: Other: controlled (automatic) massage |
| self-controlled massage | Experimental | Not described Receives: Other: controlled (automatic) massage |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This was a form that was prepared to collect information on the sociodemographic and obstetric characteristics of the participants. The form was filled when the pregnant woman was admitted to the labor room.
Measured: Delivery (when pregnant women come to the delivery room)
Visual Analogue Scale (VAS)
The participants marked the levels of pain they perceived at the end of the latent, active and transitional phases of labor on a 10-cm ruler whose two extreme points represented "no pain at all" and "unbearable pain". This is a sensitive and reliable scale in the measurement of pain severity.
Measured: Latent, active and transition phase in labor
Verbal Category Scale (VCS)
This is a one-dimensional, easy-to-apply and descriptive scale. The participants were asked to select one of the phrases "mild, uncomfortable, severe, highly severe, unbearable" that represented their pain status best.
Measured: Latent, active and transition phase of labor
Partograph
It is a graphical form that is used starting with the active phase of labor and allows the detailed monitoring of the labor process and early detection of abnormal events. It was used in this study to determine the duration of labor based on its phases and the effect of the massage intervention on this duration.
Measured: active and transition phase of labor
Individual-Controlled Massage Follow-Up Form (ICMFF)
ICMFF was a form that was developed by the researcher on which the active and transitional phases of labor were marked, and the duration and intensity of the massage that was applied were recorded by specifying the exact times. It was filled out by the researcher at the end of each massage application.
Measured: active and transition phase of labor
Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)
This scale determines the satisfaction levels of mothers regarding the care they have received at the hospital in normal vaginal labor. It is a 5-point Likert-type (1: absolutely disagree to 5: absolutely agree) scale consisting of 43 items and 10 dimensions. Thirteen items in the scale are inversely scored. The scores of these 13 items are reversed while calculating the total score of the scale. Higher total scores indicate higher levels of maternal satisfaction from the care received at the hospital in the normal vaginal labor process. The cutoff point calculated for SMSVD is 150.5, where scores higher than 150.5 indicate high satisfaction levels, and those lower than 150.5 indicate low satisfaction levels. The form was applied by the researcher in the fourth phase of labor, when the mother was taken to her bed. The authors who developed the scale determined its Cronbach's alpha internal consistency coefficient as 0.91.
Measured: within a period of 1-4 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Feb 2019
- Primary completion1 Nov 2019
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Guluzar Sade, Tarsus University
- Investigators
- Gülüzar Sade, Dr., Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237765
- Sponsor's protocol ID
- TarsusU
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
- ClinicalTrials.gov ID
- NCT05237765
- Acronym / sponsor ID
- TarsusU
- Conditions
- Massage
- Keywords
- Birth, labor duration, labor pain, massage, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 14 Feb 2022 (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.
This study was carried out to determine the effect of controlled massage applied at birth on labor pain and duration and maternal satisfaction. The study was conducted as a randomized, controlled research. The research was conducted with 154 randomized pregnant women admitted to Erzurum Nenehatun Obstetrics and Maternity hospital between February-November 2019. The study consisted of 3 different groups: Group A included the pregnant women who received routine hospital care (control group n=53), Group B included the pregnant women who received midwife-controlled massage (n=50), and the Group C consisted of the pregnant women who received self-controlled massage (n=51). It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.
Detailed description
This study was conducted to determine the effects of controlled massage applied during labor on pain during labor, labor duration and maternal satisfaction. This was a randomized-controlled experimental study.The study was carried out with the participation of 154 randomly selected pregnant women at an Obstetrics and Gynecology Hospital located in a province in the Eastern Anatolia Region of Turkey between February and November 2019.The study included three groups (A: control group, B: midwife-controlled massage group, C: self-controlled massage group). The data were collected using a "Personal Information Form", the "Visual Analogue Scale (VAS)", the "Verbal Category Scale (VCS)", a "Partograph", an "Individual-Controlled Massage Follow-Up Form" and the "Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)".It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.
IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some nonpharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.
What the results of this study add? There is no studies using thecontrolled massage. In our study, it was found that controlled massage is effective on labor birth.
What the implications are of these findings for clinical practice and/or further research? Our study suggested that midwives and pregnant women could practice controlled massage to reduce labor pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midwife-controlled massage | Experimental | Other: controlled (automatic) massage |
| self-controlled massage | Experimental | Other: controlled (automatic) massage |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having at least a primary school degree
- Not having a communication problem
- Having a primiparous term pregnancy (38-42 weeks)
- Not having an obstetric risk
- Being in the latent phase of labor (dilation 0-3cm)
Key exclusion criteria (4 listed)
- Being multiparous
- Having a high-risk pregnancy
- Being in the active or transitional phase of labor
- Having a contraindication to massage
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 |
|---|---|---|
| controlled (automatic) massageMassage methods that are performed with mechanical methods are called automated massage. Automated massage is also individual-controlled massage. This is because in automated massage, to relax, solve or reduce their pain, the individual applies the massage under their own control or under the control of someone else through a controller in a way where the duration and intensity of the massage in the body part of application vary. Individual-controlled massage devices may be in the form of chairs, cushions, beds and mattresses. These massage devices have functions such as vibrating, applying vacuum, imitating manual massage motions and applying heat. | Other | midwife-controlled massage, self-controlled massage |
Primary outcome
Personal Information Form
Time frame: Delivery (when pregnant women come to the delivery room)
This was a form that was prepared to collect information on the sociodemographic and obstetric characteristics of the participants. The form was filled when the pregnant woman was admitted to the labor room.
Visual Analogue Scale (VAS)
Time frame: Latent, active and transition phase in labor
The participants marked the levels of pain they perceived at the end of the latent, active and transitional phases of labor on a 10-cm ruler whose two extreme points represented "no pain at all" and "unbearable pain". This is a sensitive and reliable scale in the measurement of pain severity.
Verbal Category Scale (VCS)
Time frame: Latent, active and transition phase of labor
This is a one-dimensional, easy-to-apply and descriptive scale. The participants were asked to select one of the phrases "mild, uncomfortable, severe, highly severe, unbearable" that represented their pain status best.
Partograph
Time frame: active and transition phase of labor
It is a graphical form that is used starting with the active phase of labor and allows the detailed monitoring of the labor process and early detection of abnormal events. It was used in this study to determine the duration of labor based on its phases and the effect of the massage intervention on this duration.
Individual-Controlled Massage Follow-Up Form (ICMFF)
Time frame: active and transition phase of labor
ICMFF was a form that was developed by the researcher on which the active and transitional phases of labor were marked, and the duration and intensity of the massage that was applied were recorded by specifying the exact times. It was filled out by the researcher at the end of each massage application.
Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)
Time frame: within a period of 1-4 hours postpartum
This scale determines the satisfaction levels of mothers regarding the care they have received at the hospital in normal vaginal labor. It is a 5-point Likert-type (1: absolutely disagree to 5: absolutely agree) scale consisting of 43 items and 10 dimensions. Thirteen items in the scale are inversely scored. The scores of these 13 items are reversed while calculating the total score of the scale. Higher total scores indicate higher levels of maternal satisfaction from the care received at the hospital in the normal vaginal labor process. The cutoff point calculated for SMSVD is 150.5, where scores higher than 150.5 indicate high satisfaction levels, and those lower than 150.5 indicate low satisfaction levels. The form was applied by the researcher in the fourth phase of labor, when the mother was taken to her bed. The authors who developed the scale determined its Cronbach's alpha internal consistency coefficient as 0.91.
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 14 Feb 2022.
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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.
Gülüzar Sade, Dr. principal investigator
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Massage, run by Tarsus 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 4 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 14 Feb 2022. 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?
Personal Information Form (time frame: Delivery (when pregnant women come to the delivery room)). 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 14 Feb 2022.