FatigueNCT04848922
Hot Showers on Postpartum Fatigue, Mood and Comfort In Women Giving Vaginal Birth
A study testing Hot shower intervention in people with Fatigue and Comfort, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Hot shower intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2018to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue, Comfort, Mood, Postpartum Care
- Being tested
- Hot shower intervention
- Keywords
- Postpartum Maternal Health, Hot Shower, Fatigue, Comfort, Mood, Nursing-Midwifery Care
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot shower interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Took a hot shower intervention and usual care. Receives: Other: Hot shower intervention |
| Control Group | No intervention | No intervention other than usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: BMIS was assessed an hour after intervention.
Secondary outcomes (1)
Energy Scores
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.
Measured: At baseline and an hour after intervention, energy was assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start9 Apr 2018
- Primary completion13 Feb 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Rabia Atilla, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848922
- Sponsor's protocol ID
- OHU_Ratilla
- Other IDs
- TDK-2018-8319, 2017/532
- Status last verified
- May 2025
- First submitted
- 10 Apr 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Showers on Postpartum Fatigue, Mood and Comfort In Women Giving Vaginal Birth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04848922
- Acronym / sponsor ID
- OHU_Ratilla
- Conditions
- Fatigue, Comfort, Mood, Postpartum Care
- Keywords
- Postpartum Maternal Health, Hot Shower, Fatigue, Comfort, Mood, Nursing-Midwifery Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Hot shower interventionTook a hot shower intervention and usual care. |
| Control Group | No intervention | –No intervention other than usual care. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot shower interventionIntervention 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. | Other | Intervention Group |
Primary outcome
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.
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).
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.
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.
1 secondary outcome
Energy Scores
Time frame: At baseline and an hour after intervention, energy was assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot shower intervention in people with Fatigue and Comfort, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Scores (time frame: At baseline and an hour after intervention, fatigue was assessed.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.