PostpartumNCT07060755
Effect of Different Foot Baths on Postpartum Insomnia and Fatigue
A study testing Peppermint oil footbath and Warm Water Footbath in people with Postpartum, run by University of Yalova.
Trial summary
The goal of this clinical trial is to assess if different footbaths works to decrease postpartum fatigue and insomnia. The main questions are: Does peppermint oil footbaths decrease fatigue and insomnia in postpartum period? Does peppermint oil footbaths more effective than footbaths with warm water? Researchers will… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum
- What is being tested?
- Peppermint oil footbath and Warm Water Footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Giving birth at term (38-42 weeks of gestation)
- Being within the first 24 hours postpartum
- Participating in the study voluntarily
- Being over 18 years of age
Who cannot join
- Having a risky pregnancy diagnosis
- Having complications during and after birth
- Having a cardiovascular system disease diagnosis
- Having an open wound in the foot area
- Having any skin problems in the foot area (such as fungus)
- Having communication problems
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Foot Bath With Peppermint Oil on Postpartum Insomnia and Fatigue Compared to Foot Bath With Warm Water Alone in the Postpartum Period
The goal of this clinical trial is to assess if different footbaths works to decrease postpartum fatigue and insomnia. The main questions are:
Does peppermint oil footbaths decrease fatigue and insomnia in postpartum period? Does peppermint oil footbaths more effective than footbaths with warm water?
Researchers will compare peppermint oil footbath, warm water footbath to no intervention.
Participants will:
Answer some scales and questionnaire. Do peppermint oil footbath or warm water footbath for 30 minutes each day postpartum during 2 weeks.
- Conditions
- Postpartum
- Being tested
- Peppermint oil footbath, Warm Water Footbath
- Keywords
- fatigue, insomnia, sleepiness, footbath
- Medical subject headings
- Fatigue, Sleep Initiation and Maintenance Disorders, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint oil footbathOther
This includes a footbath with peppermint oil for 30 minutes each day for 2 weeks
Warm Water FootbathOther
This includes a warm water footbath for 30 minutes each day dor 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Peppermint Oil Bath Group | Experimental | This arm will have peppermint oiled footbath Receives: Other: Peppermint oil footbath |
| Warm water Bath Group | Experimental | This arm will have warm water footbath Receives: Other: Warm Water Footbath |
| Control | No intervention | This arm will have no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue will be assessed via Postnatal Accumulated Fatigue Scale. This scale used to assess the fatigue levels of postpartum women in the postpartum period. The scale consists of a total of 13 items and 3 sub-dimensions answered as "almost none," "sometimes," and "mostly." The items of the scale are scored between 0 and 3, and as the total score increases, it is interpreted that the individual's fatigue increases. The scale has no cut-off score.
Measured: 1st day to the 14th day
Postpartum Sleep Quality
Postpartum Sleep Quality Scale will use to assess sleep quality. This scale aims to evaluate sleep quality in the postpartum period. The scale has a 5-point Likert structure and consists of a total of 14 items and three sub-dimensions. Scale items are scored between 0 and 4. The score that can be obtained from the scale varies between 0-56.
Measured: 1st day to 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Balkan, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060755
- Sponsor's protocol ID
- EBSOYalova
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publicly due to ethical restrictions. But authors may share IPD with researchers who reach out to the authors for data sharing with necessary reasons
Publications
Kirca AS, Gul DK, Sener N. Psychometric properties of postnatal accumulated fatigue scale validity and reliability. J Obstet Gynaecol Res. 2023 Jul;49(7):1762-1769. doi: 10.1111/jog.15651. Epub 2023 Apr 23.
PubMed 37088932
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Bath With Peppermint Oil on Postpartum Insomnia and Fatigue Compared to Foot Bath With Warm Water Alone in the Postpartum Period
- ClinicalTrials.gov ID
- NCT07060755
- Acronym / sponsor ID
- EBSOYalova
- Conditions
- Postpartum
- Keywords
- fatigue, insomnia, sleepiness, footbath
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Jul 2025 (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 goal of this clinical trial is to assess if different footbaths works to decrease postpartum fatigue and insomnia. The main questions are:
Does peppermint oil footbaths decrease fatigue and insomnia in postpartum period? Does peppermint oil footbaths more effective than footbaths with warm water?
Researchers will compare peppermint oil footbath, warm water footbath to no intervention.
Participants will:
Answer some scales and questionnaire. Do peppermint oil footbath or warm water footbath for 30 minutes each day postpartum during 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peppermint Oil Bath Group | Experimental | Other: Peppermint oil footbathThis arm will have peppermint oiled footbath |
| Warm water Bath Group | Experimental | Other: Warm Water FootbathThis arm will have warm water footbath |
| Control | No intervention | –This arm will have no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Giving birth at term (38-42 weeks of gestation)
- Being within the first 24 hours postpartum
- Participating in the study voluntarily
- Being over 18 years of age
Key exclusion criteria (6 listed)
- Having a risky pregnancy diagnosis
- Having complications during and after birth
- Having a cardiovascular system disease diagnosis
- Having an open wound in the foot area
- Having any skin problems in the foot area (such as fungus)
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 |
|---|---|---|
| Peppermint oil footbathThis includes a footbath with peppermint oil for 30 minutes each day for 2 weeks | Other | Peppermint Oil Bath Group |
| Warm Water FootbathThis includes a warm water footbath for 30 minutes each day dor 2 weeks | Other | Warm water Bath Group |
Primary outcome
Fatigue
Time frame: 1st day to the 14th day
Fatigue will be assessed via Postnatal Accumulated Fatigue Scale. This scale used to assess the fatigue levels of postpartum women in the postpartum period. The scale consists of a total of 13 items and 3 sub-dimensions answered as "almost none," "sometimes," and "mostly." The items of the scale are scored between 0 and 3, and as the total score increases, it is interpreted that the individual's fatigue increases. The scale has no cut-off score.
Postpartum Sleep Quality
Time frame: 1st day to 14th day
Postpartum Sleep Quality Scale will use to assess sleep quality. This scale aims to evaluate sleep quality in the postpartum period. The scale has a 5-point Likert structure and consists of a total of 14 items and three sub-dimensions. Scale items are scored between 0 and 4. The score that can be obtained from the scale varies between 0-56.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 37088932Kirca AS, Gul DK, Sener N. Psychometric properties of postnatal accumulated fatigue scale validity and reliability. J Obstet Gynaecol Res. 2023 Jul;49(7):1762-1769. doi: 10.1111/jog.15651. Epub 2023 Apr 23.
- Individual participant dataSharing planned: No. IPD will not be shared publicly due to ethical restrictions. But authors may share IPD with researchers who reach out to the authors for data sharing with necessary reasons
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint oil footbath and Warm Water Footbath in people with Postpartum, run by University of Yalova.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Balkan, PhD Student (+905423513125, elif.balkan@yalova.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 1st day to the 14th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07060755, which also lists 1 linked publication.
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 15 Aug 2025.