NCT06183957

Brief Summary

According to the definition of the International Association for the Study of Pain, pain; It is an unpleasant sensory and emotional sensation and behavior related to the individual's past experiences, caused by real or potential tissue damage originating from any part of the body. Birth pain is the most severe pain experience known and defined, with physiological as well as psychological and sociocultural components that may vary among individuals.Pharmacological and non-pharmacological applications are used to relieve birth pain. While pharmacological methods reduce pain, they distract women from the physiological reality of birth and prevent women from accepting pain as a natural part of birth. Non-pharmacological methods are alternative options that will help women manage pain during birth by ensuring that women experience pain. Showering (hydrotherapy), one of the non-pharmacological methods used to reduce pain in labor, is used to increase relaxation and reduce birth pain. In a study conducted domestically, it was stated that the use of hydrotherapy during labor pain helped the woman relax, reduced the pain felt, lowered blood pressure and increased diuresis. Fatigue, in addition to being a universal symptom associated with diseases, is also a common complaint among healthy individuals. In line with the literature information, this study aims to examine the effect of shower applied during birth on postpartum fatigue and postpartum comfort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

December 12, 2023

Last Update Submit

June 4, 2024

Conditions

Keywords

Postpartum periodPostpartum comfortHydrotherapy

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    sociodemographic characteristics, medical and obstetric pregnancy history, the woman's current pregnancy, prenatal and postpartum period

    1 week

Secondary Outcomes (3)

  • Visual Comparison Scale (VAS)

    during labour period (up to 10 hours)

  • Postpartum Comfort Scale (WSCO)

    between 2-4 hours postpartum period

  • Person-Oriented Maternity Care Scale

    between 2-4 hours postpartum period

Study Arms (2)

hydrotherapy group

EXPERIMENTAL

When women in this group are taken to their labor rooms (when the dilation is 4-5cm), they should be standing or standing, depending on their preferences, on their waist, abdomen or whole body, with the temperature of the water between 32-37 °C (the temperature preferred by the woman will be applied) for at least 20 minutes. Sitting shower application will be performed under the observation of the researcher midwife. The temperature of the flowing water will be measured with a bucket and a thermometer that helps evaluate the temperature. The application will be repeated when the dilation is 6-8 cm.

Other: hydrotherapy group

Control group

NO INTERVENTION

Women in this group will not undergo any treatment other than routine hospital protocol (midwifery care). Additionally, the vital signs (blood pressure, pulse) of the participants will be measured and recorded hourly by the midwife. These data will be recorded in each participant's file.

Interventions

When women in this group are taken to their labor rooms (when the dilation is 4-5cm), they should be standing or standing, depending on their preferences, on their waist, abdomen or whole body, with the temperature of the water between 32-37 °C (the temperature preferred by the woman will be applied) for at least 20 minutes. Sitting shower application will be performed under the observation of the researcher midwife. The temperature of the flowing water will be measured with a bucket and a thermometer that helps evaluate the temperature. The application will be repeated when the dilation is 6-8 cm.

hydrotherapy group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily agreeing to participate in the study
  • She will have her second birth spontaneously vaginally at term (between 37-42 weeks of pregnancy).
  • The fetal weight estimated by ultrasound is 2500-4000 grams
  • Single fetus and head presentation
  • Being in the active phase of labor (cervical dilation 4 cm)
  • Ability to establish written/verbal communication
  • Not taking any analgesia or anesthesia to relieve pain and fatigue before birth and during labor.
  • Newborn APGAR score is 7 or above

You may not qualify if:

  • giving up on research
  • Having received infertility treatment
  • Birth by cesarean section
  • Having an interventional birth (forceps, vacuum, episiotomy application)
  • Being primiparous, having a third or more birth (grandmultiparous)
  • Having any systemic, chronic and neurological disease (Diabetes Mellitus, Hypertension, Thyroid diseases, Multiple Sclerosis, Epilepsy, etc.)
  • Regular use of medication due to any disease
  • Receiving psychiatric treatment (pharmacotherapy/psychotherapy)
  • Any induction application that will affect uterine contractions and dilation
  • Having any pregnancy complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios and polyhydramnios, contraction anomalies, presentation disorder, intrauterine growth retardation, intrauterine dead fetus, macrosomic babies, fetal distress, etc.)
  • Having any problem that prevents communication (such as not knowing Turkish, hearing, speaking and understanding impairment),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Çorlu District State Hospital

Tekirdağ, Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ZEYNEP CAMBAZ

    Tekirdağ Çorlu İlçe Devlet Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate professor

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 28, 2023

Study Start

March 3, 2023

Primary Completion

December 15, 2023

Study Completion

February 29, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations