Clinical trial NCT05179915: Effect of Therapeutic Touch on Labor Pain and Hormone Levels
Official title: The Effect of Sacral Region-focused Therapeutic Touch Applied During the Latent Phase of Labour on Hormone Levels, Labour Comfort and Perception: A Randomized Sham Controlled Trialt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Touch
Childbirth
Keywords: Labor Pain
Therapeutic Touch
Childbirth
Hormones
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized sham controlled trial design was used in the study, which was conducted with 50 primiparous pregnant women. While Therapeutic Touch (25) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (25) was applied in the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.

A randomized sham controlled trial design was used in the study, which was conducted with 50 primiparous pregnant women. While Therapeutic Touch (25) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (25) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale, a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire and the Perception of Birth Scale.

Keywords: Labor Pain,Therapeutic Touch, Childbirth, Hormones

Detailed description: Aim: This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.

Method: This randomised sham controlled experimental trial was conducted with two groups (intervention and control groups) in a state hospital between 08 March 2022 and 01 April 2023. The sample size of the study was calculated using the G\*power 3.1.9.6 programme. As a result of the calculation, twenty-five pregnant women for each group were included in the study. While Therapeutic Touch (TT) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (STT) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale (VAS), a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire (CCQ) and the Perception of Birth Scale (PBS). IBM SPSS V25 programme was used for statistical analysis of the study. The statistical significance was assessed at the level of p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Being primipara,
* Having a gestational age of 38-42 weeks,
* Planning to have a normal vaginal delivery,
* Having a 3-4 cm dilation in the latent phase,
* Having a single fetus and head presentation,
* Speaking and communicating in Turkish,
* Agreeing to participate in the study,
* Having no high-risk pregnancy.

Exclusion Criteria:

* Receiving induction,
* Receiving labor analgesia/anesthesia,
* Having sensitivity or problems with touch,
* Having to leave during the intervention due to some reasons such as medical procedures, etc.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: VAS were evaluated after application 30 minutes in each groups.
Secondary outcomes:
measure: The Perception of Birth Scale (PBS)
timeFrame: PBS were evaluated after delivery in each groups.
Other outcomes:
measure: The Childbirth Comfort Questionnaire (CCQ)
timeFrame: CCQ were evaluated after application 30 minutes in each groups.
measure: Hormones
timeFrame: a maternal saliva sample for hormones was took pretest and posttest (after application in 30 minutes).
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıcam
Study officials:
affiliation: Cukurova University
name: Ebru Gözüyeşil, PhD. Associate Professor,
role: PRINCIPAL_INVESTIGATOR
References: