The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process

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.

Study Overview

• Status: Completed
• Conditions: Massage; Midwifery; Labor Delivery
• Intervention / Treatment: Other: Back and Sacral massage 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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Ayşe Nur Ataş

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midwife Massage Experimental Group (1); 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.	Other: Back and Sacral massage massage application; 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.
Experimental: Spouse Massage Experimental Group (2); 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.	Other: Back and Sacral massage massage application; 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.
No Intervention: Control Group; It will be perform routine practice who the women in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
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.),	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.),	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 membranesUterine contractions (number per 10 minutes and duration)Drugs administered (oxytocin, antibiotics, etc.); Foetal indicators:Foetal heart rateAmniotic fluid (colour, odour and quantity)Descent of the foetal head and head moulding	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."	in the first 24 hours postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Massage Application Satisfaction Evaluation Scale and Form	The "Visual Analog Scale (VAS)", which can be easily understood by individuals and applied to many different groups, has been adapted to similar usage principles. VAS is used to make some values that cannot be measured numerically measurable. It is planned to use this scale to evaluate the satisfaction of the women in the study group with the massage application. As a result of the application, the numbers between 0 and 10, which they will indicate by showing the point corresponding to the satisfaction with the process, are placed on a vertical line. On the scale, 0 points means "I am not satisfied at all" with the application, and 10 points means "I am very satisfied" with the application. In addition, with the questionnaire prepared by the researcher, the participants were asked whether the application would be beneficial, whether they would prefer it again, whether they would recommend it to others, and their suggestions and dislikes about the application with 7 questions.	in the first 24 hours postpartum
Evaluation Scale and Form of Satisfaction with Travay Process	The "Visual Analog Scale (VAS)", which can be easily understood by individuals and applied to many different groups, has been adapted to similar usage principles. It is planned to use this scale to evaluate the satisfaction with the labor process in all women in the study group.	in the first 24 hours postpartum

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Ayşe Nur Ataş, Necmettin Erbakan University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pain; anxiety; Labor; massage; partner massage
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 0000-0003-3096-3599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No