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Completed

NCT Number: NCT05720962

The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Universty Cerrahpaşa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

uninterrupted accompanying support

Procedure

When the participants in the experimental group are taken to the delivery unit, when the neck dilation is 4 cm, a person they want will be taken with them to support them.

Afterwards, the pain status and satisfaction of the participants will be questioned when it is 4 cm, 6 cm, 8 cm and 10 cm.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: "through study completion, an average of 1 year"

    It is a reliable and easily applicable scale accepted in the world literature. It is used to measure the values that cannot be measured numerically in the evaluation of the pain intensity and satisfaction of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. Additionally, higher scores indicate higher pain intensity, higher satisfaction.

  2. Personal information form

    Time frame: "through study completion, an average of 1 year".

    It is a form that includes questions that determine socio-demographic characteristics and perception of support. The form also includes questions about the process of the birth period.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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