Clinical trial NCT05720962: The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction
Official title: The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Birth Support
Keywords: continuous birth support
birth time
labor pain
satisfaction
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study with two groups as control and experimental group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.

Detailed description: Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.

This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".

The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.

Eligibility criteria: Inclusion Criteria:

* 18-35 years old
* Being literate
* Fluent and speaking Turkish
* Primiparous
* Spontaneous vaginal delivery planned
* At the beginning of the active phase (dilatation 4 cm)
* Pregnant women who agreed to participate in the research

Exclusion Criteria:

* Presence of a health problem in the mother during pregnancy
* At risk of fetal anomaly
* Having multiple pregnancy
* Administering analgesic medication during labor

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: "through study completion, an average of 1 year"
measure: Personal information form
timeFrame: "through study completion, an average of 1 year".
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Universty Cerrahpaşa
Study officials:
affiliation: Msc Midwife
name: Dilan Cömert
role: PRINCIPAL_INVESTIGATOR
References: