Clinical trial NCT05734885: The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process
Official title: The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midwifery
Labor Delivery
Massage
Keywords: Labor
massage
partner massage
pain
anxiety
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 135
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size of the study was calculated based on the results of a study aiming to determine the effect of birth dance applied with the support of a spouse and midwife during labor on birth pain and satisfaction \[19\]. It was found as 116 participants, including 39 in each group, on the G\*power 3.1.9.2 (Ver. 3.1.9.2) \[20\] software, based on an effect size of 0.71, a power of 0.95, and an alpha level of 0.05. Considering some attrition, an additional 15% was added to the sample size, and the study was planned to be conducted with 141 women (47 in the partner massage group, 47 in the midwife massage group, and 47 in the control group). During monitoring, two participants were lost from each group. Eventually, the study was completed with a total of 135 women, 45 in each group.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnant Introduction Form
timeFrame: in active phase on labor (4 cm and less vaginal dilatation)
measure: Labor Monitoring Form
timeFrame: in labor and in the first 24 hours postpartum
measure: Partograph
timeFrame: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
measure: Visual Analog Skala-VAS
timeFrame: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
measure: Spielberger State Anxiety Scale
timeFrame: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)
measure: Assessment of Satisfaction Scale
timeFrame: in the first 24 hours postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Ayşe Nur Ataş
Study officials:
affiliation: Necmettin Erbakan University, Faculty of Medicine
name: Ayşe Nur Ataş
role: PRINCIPAL_INVESTIGATOR
References: