NCT04848922

Brief Summary

The aim of this study to determine the effect of hot showers on postpartum fatigue, mood and comfort in women giving vaginal birth. 136 women, who were between 6 and 12 hours postpartum, were assigned to intervention and control groups by computer randomization. Visual Similarity Scale for Fatigue, Visual Analogue Scale, Postpartum Comfort Questionnaire and Brief Mood Insight Scale were used to collect data. The women in the intervention group were allowed to take a shower in a standing position at a water temperature of 37-41°C for 10-20 minutes. In the control group, routine care was provided.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

April 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

April 10, 2021

Last Update Submit

May 20, 2025

Conditions

Keywords

Postpartum Maternal HealthHot ShowerFatigueComfortMoodNursing-Midwifery Care

Outcome Measures

Primary Outcomes (4)

  • Fatigue Scores

    Fatigue assessed using by The Visual Similarity Scale for Fatigue (VSSF) and Visual Analog Scale (VAS-F). The Visual Similarity Scale for Fatigue (VSSF) consists of 18 items in two sub-dimensions, comprising fatigue (13 items) and energy (5 items) sub-dimensions. The scale consists of 10-cm horizontal lines that contain positive expressions at one end and negative expressions at the other end. The intersection point at the marked location is evaluated objectively by measuring it with a ruler separately for each question. The score range in the sub-dimension of fatigue is 0-130. Visual Analog Scale (VAS-F) is a scale on a 10 cm long vertical line with two ends named differently (0 = I am not tired and 10 = I am extremely tired). The distance between the marked point and the lowest end of the line (0 = I'm not tired) is measured in centimeters and the numerical value found indicates the patient's fatigue severity.

    At baseline and an hour after intervention, fatigue was assessed.

  • Comfort Scores

    Comfort assessed using by Postpartum Comfort Questionnaire (PPCQ). Postpartum Comfort Questionnaire (PPCQ) which is a five-point likert type scale, has 34 items and the total score is 34-170. The scale has three sub-dimensions: "physical, psycho-spiritual and sociocultural". The comfort score is expressed as the average value, obtained by dividing the total score by the number of items. The average value found is shown in a distribution of 1 (low comfort) to 5 (high comfort).

    PPCQ was assessed an hour after intervention.

  • Discomfort Scores

    Discomfort assessed using by Visual Analog Scale for Discomfort (VAS-D). Visual Analog Scale for Discomfort (VAS-D) is a scale on a 10 cm long vertical line with two ends named differently (0 = No discomfort and 10 = Extremely discomfort). The distance between the marked point and the lowest end of the line (0 = No discomfort) is measured in centimeters and the numerical value found indicates the patient's discomfort severity.

    VAS-D was assessed at baseline and an hour after intervention.

  • Mood Scores

    Brief Mood Insight Scale (BMIS) which is likert type scale, has 16 items with four scores (1 (absolutely not) -4 (absolutely feel)) and the total score is 8-32. High scores for both subscales indicate high positive or negative mood.

    BMIS was assessed an hour after intervention.

Secondary Outcomes (1)

  • Energy Scores

    At baseline and an hour after intervention, energy was assessed.

Other Outcomes (1)

  • Opinions about Postpartum Hot Showers İntervention

    PFF was assessed an hour after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Took a hot shower intervention and usual care.

Other: Hot shower intervention

Control Group

NO INTERVENTION

No intervention other than usual care.

Interventions

Intervention group took a shower in a standing position at a water temperature of 37-41°C for 10-20 minutes between 6 and 12 hours after vaginally birth.

Intervention Group

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Puerperal women who were aged 19 and over,
  • Educated to at least primary school level,
  • Have a vaginal delivery,
  • To be between 6 and 12 hours postpartum duration ,
  • Having a single and healthy newborn,
  • Mobilized.

You may not qualify if:

  • Puerperal women with a history of chronic illness
  • Puerperal women with a history of psychiatric illness
  • Any risk diagnosed pregnancy (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
  • Any complications related to the mother and baby in birth period (dystocia,operative birth, bleeding, hypertension),
  • Any complications related to the mother and baby in the postpartum period (bleeding, hypo-hypertension, babies taken to the neonatal intensive care unit, a body temperature of 38 °C or above, positive Homan's sign etc.).
  • Have a body mass index of 40 or above
  • Have Anemic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 19, 2021

Study Start

April 9, 2018

Primary Completion

February 13, 2019

Study Completion

November 25, 2019

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations