The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
Primary Purpose
Massage
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
controlled (automatic) massage
Sponsored by
About this trial
This is an interventional supportive care trial for Massage focused on measuring Birth, labor duration, labor pain, massage, satisfaction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Being multiparous
- Having a high-risk pregnancy
- Being in the active or transitional phase of labor
- Having a contraindication to massage
Sites / Locations
- Tarsus University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
midwife-controlled massage
self-controlled massage
control group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05237765
First Posted
January 14, 2022
Last Updated
February 11, 2022
Sponsor
Tarsus University
Collaborators
Ataturk University
1. Study Identification
Unique Protocol Identification Number
NCT05237765
Brief Title
The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
Official Title
The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tarsus University
Collaborators
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage
Keywords
Birth, labor duration, labor pain, massage, satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
midwife-controlled massage
Arm Type
Experimental
Arm Title
self-controlled massage
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
controlled (automatic) massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Personal Information Form
Description
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.
Time Frame
Delivery (when pregnant women come to the delivery room)
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Latent, active and transition phase in labor
Title
Verbal Category Scale (VCS)
Description
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.
Time Frame
Latent, active and transition phase of labor
Title
Partograph
Description
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.
Time Frame
active and transition phase of labor
Title
Individual-Controlled Massage Follow-Up Form (ICMFF)
Description
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.
Time Frame
active and transition phase of labor
Title
Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)
Description
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.
Time Frame
within a period of 1-4 hours postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Being multiparous
Having a high-risk pregnancy
Being in the active or transitional phase of labor
Having a contraindication to massage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülüzar Sade, Dr.
Organizational Affiliation
Tarsus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tarsus University
City
Mersin
Country
Turkey
12. IPD Sharing Statement
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The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
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