- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05237765
The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mersin, Turkey
- Tarsus University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: midwife-controlled massage
|
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.
|
Experimental: self-controlled massage
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Delivery (when pregnant women come to the delivery 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.
|
Latent, active and transition phase in labor
|
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.
|
Latent, active and transition phase of labor
|
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.
|
active and transition phase of labor
|
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.
|
active and transition phase of labor
|
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.
|
within a period of 1-4 hours postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gülüzar Sade, Dr., Tarsus University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TarsusU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Massage
-
Indiana UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedMassageUnited States
-
Jagiellonian UniversityCompletedMassage | SpirometryPoland
-
National Taiwan University HospitalCompleted
-
Claremont Graduate UniversityGruter InstituteCompleted
-
Istanbul University - Cerrahpasa (IUC)CompletedOxytocin | Breastfeeding | Music | MassageTurkey
-
Cooperativa de Ensino Superior, Politécnico e UniversitárioCompleted
-
Sultan BesiktasNot yet recruitingStress | Newborn | Massage | Comfort
-
Mohammed Ali FAKHRO, DPTCompleted
-
Alexandria UniversityRecruitingSelf-affirmation, Back MassageEgypt
-
Ege UniversityCompletedPregnancy Related | Fetus Fetus | Massage TherapyTurkey
Clinical Trials on controlled (automatic) massage
-
Busra LekesizNot yet recruitingCesarean Section Complications | Postpartum Hemorrhage | Uterine Atony
-
Fondazione C.N.R./Regione Toscana "G. Monasterio...Weinmann Geräte für Medizin GmbH + Co. KGCompletedObstructive Sleep Apnea SyndromeItaly
-
Ataturk UniversityMSc Reyhan YALÇIN; MSc Meral Güven; PhD Adem ASLANCompletedPain | Stress | NewbornTurkey
-
William Marsh Rice UniversityCompletedPre EclampsiaUnited States
-
Norwegian University of Science and TechnologySt. Olavs HospitalRecruitingProstate Cancer DiagnosisNorway
-
National Taiwan University HospitalUnknownCardiac Arrest | Cardiopulmonary ResuscitationTaiwan
-
Southeast University, ChinaRecruiting
-
McMaster UniversityThe Physicians' Services Incorporated FoundationCompleted
-
Philips HealthcareCompletedMyocardial Infarction | Renal Failure | Cardiac Arrest | Severe Sepsis | Respiration FailureUnited Kingdom
-
National Taiwan University HospitalRecruiting