Effect of Different Foot Baths on Postpartum Insomnia and Fatigue

NCT07060755 | Not Yet Recruiting

• 1 other identifier: EBSOYalova
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postpartum

Keywords

fatigue; insomnia; sleepiness; footbath

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1st day to 14th day

Study Arms (3)

Peppermint Oil Bath Group

EXPERIMENTAL

This arm will have peppermint oiled footbath

Other: Peppermint oil footbath

Warm water Bath Group

EXPERIMENTAL

This arm will have warm water footbath

Other: Warm Water Footbath

Control

NO INTERVENTION

This arm will have no intervention

Interventions

Peppermint oil footbath OTHER

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

Peppermint Oil Bath Group

Warm Water Footbath OTHER

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

Warm water Bath Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender people identify with the gender that aligns with the sex they were assigned at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Yalova: lead

Related Publications (1)

• 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.

  PMID: 37088932 BACKGROUND

MeSH Terms

Conditions

Fatigue; Sleep Initiation and Maintenance Disorders; Sleepiness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Elif Balkan, PhD Student

CONTACT

+905423513125; elif.balkan@yalova.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 11, 2025
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share