Clinical trial NCT04848922: Hot Showers on Postpartum Fatigue, Mood and Comfort In Women Giving Vaginal Birth
Official title: The Effect of Hot Showers on Postpartum Fatigue, Mood and Comfort In Women Giving Vaginal Birth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Comfort
Mood
Postpartum Care
Keywords: Postpartum Maternal Health
Hot Shower
Fatigue
Comfort
Mood
Nursing-Midwifery Care
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2021-04-19
Enrollment: 136
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Scores
timeFrame: At baseline and an hour after intervention, fatigue was assessed.
measure: Comfort Scores
timeFrame: PPCQ was assessed an hour after intervention.
measure: Discomfort Scores
timeFrame: VAS-D was assessed at baseline and an hour after intervention.
measure: Mood Scores
timeFrame: BMIS was assessed an hour after intervention.
Secondary outcomes:
measure: Energy Scores
timeFrame: At baseline and an hour after intervention, energy was assessed.
Other outcomes:
measure: Opinions about Postpartum Hot Showers İntervention
timeFrame: PFF was assessed an hour after intervention
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
References: