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

Massage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05734885
• Other study ID #: 0000-0003-3096-3599
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

H1-1 = Spousal massage during the active phase of labor reduces perceived labor pain.

H1-2 = Spousal massage applied during the active phase of labor reduces the state anxiety of the woman.

H1-3= Spousal massage applied during the active phase of labor affects the birth process (active phase and labor duration, labor with intervention).

H1-4= Spouse massage applied in the active phase of labor increases the satisfaction level of women from massage application.

Description:

vSupporting 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: March 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Massage
• Midwifery

Intervention

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 applied. The massage is completed by making a bunch of flowers from the sacrum upwards, towards the shoulder and around it.

Locations

Country	Name	City	State
Turkey	Ayse Nur Atas	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnant Introduction Form	The personal information form prepared by the researchers based on the literature consists of 3 parts. First part; It consists of 10 questions that include some socio-demographic characteristics of pregnant women (such as age, education level, marital status, social security status). Second part; Out of 13 questions including obstetric characteristics of pregnant women (week of pregnancy, desire for pregnancy, having problems during pregnancy, receiving prenatal education); The third part consists of 5 questions about the characteristics of the spouses of pregnant women	in active phase on labor (4 cm and less vaginal dilatation)
Primary	Birth Monitoring Form	The labor follow-up form, the practices for the pregnant women (starting and ending time of the application, the length of the first and second stages of the labor, the interventions applied in the labor (forceps, vacuum, etc.) and the characteristics of the newborn in the postpartum period (apgar score, newborn weight) It consists of 18 questions evaluating	in labor and in the first 24 hours postpartum
Primary	Partograph	The partograph is a tool for monitoring maternal and foetal wellbeing during the active phase of labour, and a decision-making aid when abnormalities are detected. It is designed to be used at any level of care.; 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	in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
Primary	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)
Primary	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)
Secondary	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
Secondary	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