ClinicalTrials.gg
Not yet recruitingNCT07060755Updated Aug 15, 2025

Effect of Different Foot Baths on Postpartum Insomnia and Fatigue

An interventional study of Peppermint oil footbath and Warm Water Footbath in Postpartum, sponsored by University of Yalova. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by University of Yalova · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Postpartum

Keywords

  • fatigue
  • insomnia
  • sleepiness
  • footbath
03

In context

Fatigue

2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.

This study's planned enrollment of 90 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

University of Yalova is the lead sponsor of 61 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Peppermint Oil Bath Group

    This arm will have peppermint oiled footbath

    Other: Peppermint oil footbath

  • Experimental
    Warm water Bath Group

    This arm will have warm water footbath

    Other: Warm Water Footbath

  • No intervention
    Control

    This arm will have no intervention

Interventions

  • OtherPeppermint oil footbath

    This includes a footbath with peppermint oil for 30 minutes each day for 2 weeks

  • OtherWarm Water Footbath

    This includes a warm water footbath for 30 minutes each day dor 2 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1st day to the 14th day

  2. 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.

    Time frame: 1st day to 14th day

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: 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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2025; primary completion for Sep 2025, 0 months later.

Of 936 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 0 months is below that.

Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2025
First posted
Jul 11, 2025
StartEst.
Sep 1, 2025
Primary completionEst.
Sep 1, 2025
CompletionEst.
Sep 30, 2026
Last update
Aug 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07060755
Lead sponsor
University of Yalova
Responsible party
Elif Balkan (Research Assistant, University of Yalova) — Principal investigator
First posted
Jul 11, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 15, 2025

Study contacts

Elif Balkan, PhD Student
Contact
elif.balkan@yalova.edu.tr
+905423513125

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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