Hot Showers on Postpartum Fatigue, Mood and Comfort In Women Giving Vaginal Birth

April 13, 2021 updated by: Rabia Atilla, Nigde Omer Halisdemir University

The Effect of Hot Showers on Postpartum Fatigue, Mood and Comfort In Women Giving Vaginal Birth: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Evidence has been limited on the effect of hot showers on postpartum fatigue, mood, and comfort in women giving vaginal birth. This study aimed to determine such effects in a randomized controlled trial conducted in a hospital in Turkey. Participants were recruited from a hospital located in the Nigde province in the Central Anatolia region in Turkey. The data of the research were collected between 9 April 2018 and 13 February 2019.

Puerperal women who had given birth in vaginal way and who were in the maternity ward of the hospital and who were between 6 and 12 hours postpartum were included in the study. The computer-generated randomization list was prepared by an independent biostatistician using the PASS program (PASS 11.0.4, NCSS, LL. Kaysville, Utah, and USA). Women who met the inclusion criteria were randomized into intervention group (IG) and the control group (CG) based on age and parity status (through one-to-one matching) by computer. A total of 128 volunteers, 64 in each group, were included in the study in order to be able to determine an effect size of 0.5 between the two groups, with an error risk of α = 0.05 and 80% power ratio to represent the medium effect size using Cohen's (1988) effect size. However, it was predicted that there might be withdrawals during the study, and 136 women, 68 in each group, were included in the study.

Puerperium Introduction Form (PIF), Puerperium Follow-Up Form (PFF), Visual Similarity Scale for Fatigue (VSSF), Visual Analogue Scale for Fatigue and Disomfort (VAS-F and VAS-D), Postpartum Comfort Questionnaire (PPCQ) and Brief Mood Insight Scale (BMIS) were used to collect data.

At the first interview, 6 and 12 hours postpartum, PIF, VAS for fatigue and discomfort, and VSSF were filled in for the puerperal women in the Intervention Group (IG) and Control Group (CG). In the CG, women were provided routine care practices in the postnatal care unit of the hospital. In the IG, in addition to the routine care practices of the clinic, a hot shower at a standing position was provided. The temperature of the water was adjusted according to the preferences of the women to between 37 and 41 °C with a digital shower thermometer, and the women were allowed to shower for 10-20 minutes in a standing position. After the shower procedures, the information on and individual views of the puerperal women were recorded in the PFF. One hour after the completion of the hot shower procedure, the VAS for fatigue and discomfort, the VSSF, the PPCQ, and BMIS were filled in for the final test.

Data analyses were conducted using IBM SPSS 25.0 software. Chi-square and t statistical tests were used to to determine whether the socio-demographic and obstetric characteristics. For numerical variable comparisons between groups were evaluated using two independent samples t-test for variables that provide normal distribution assumption, and the Mann-Whitney U test for variables that do not provide a normal distribution assumption. For numerical variables, the comparisons of the groups over time were made with Repeated Measures ANOVA. The Bonferroni test was used as a multiple comparison test. In cases where p <.05, the difference between groups was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Niğde, Turkey, 51200
        • Nigde Omer Halisdemir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
Took a hot shower intervention and usual care.
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.
NO_INTERVENTION: Control Group
No intervention other than usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Scores
Time Frame: At baseline and an hour after intervention, fatigue was assessed.

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
Time Frame: PPCQ was assessed an hour after intervention.
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
Time Frame: VAS-D was assessed at baseline and an hour after intervention.
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
Time Frame: BMIS was assessed an hour after intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Scores
Time Frame: At baseline and an hour after intervention, energy was assessed.
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 0-50 in the sub-dimension of energy.
At baseline and an hour after intervention, energy was assessed.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opinions about Postpartum Hot Showers İntervention
Time Frame: PFF was assessed an hour after intervention
Puerperium Follow-Up Form (PFF): This is a form consisting of a total of three questions, in which are recorded the individual views of members of the intervention group regarding the duration of the shower procedure and the negative effects that may have been experienced. In addition, there is a question regarding the control group's views on postpartum shower application.
PFF was assessed an hour after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 9, 2018

Primary Completion (ACTUAL)

February 13, 2019

Study Completion (ACTUAL)

November 25, 2019

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHU_Ratilla
  • TDK-2018-8319 (OTHER_GRANT: Erciyes University)
  • 2017/532 (OTHER: Erciyes University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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