NCT05212376

Brief Summary

This study will be carried out to determine the effect of foot massage applied to menopausal women on anxiety, fatigue and sleep levels. This randomized controlled study will be conducted with 70 women (35 experimental, 35 control) residing in a village in northern Turkey. In the study, women in the experimental group will be given foot massage once a day for 7 days. No intervention will be applied to the women in the control group. Research data will be collected using "Personal Information Form", "Fatigue Severity Scale" and "Beck Anxiety Inventory". Descriptive statistics (number, percentage distribution, median and Q1-Q3), chi-square test, Mann Whitney-U test and Wilcoxon test will be used in the analysis of the data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

13 days

First QC Date

January 11, 2022

Last Update Submit

June 19, 2022

Conditions

Keywords

MenopauseFatigueAnxietySleepFoot massage

Outcome Measures

Primary Outcomes (1)

  • Sleep level in women with menopause

    In order to determine the socio-demographic (age, education, employment, income, family type, etc.), obstetric (pregnancy, abortion, number of children, etc.), health status (chronic illness, drug use, etc.) and sleep patterns of women, the researchers It is a form consisting of 25 questions developed by.

    Thumb pressure application, swiping, patting, rubbing and squeezing movements were applied to each foot for a total of 20 minutes for 10 minutes, once at the same time every day for 7 days.

Secondary Outcomes (2)

  • Fatigue level in women with menopause

    Thumb pressure application, swiping, patting, rubbing and squeezing movements were applied to each foot for a total of 20 minutes for 10 minutes, once at the same time every day for 7 days.

  • Anxiety level in women with menopause

    Thumb pressure application, swiping, patting, rubbing and squeezing movements were applied to each foot for a total of 20 minutes for 10 minutes, once at the same time every day for 7 days.

Study Arms (2)

Foot massage

EXPERIMENTAL

Foot massage (reflexology) is an application that allows the individual to relax, reduce stress, and thus restore the balance of the body by stimulating the nerve cells in the legs.It is stated that reflexology is an effective complementary treatment method that can help the body relax, reduce the symptoms of menopause by affecting the nervous and endocrine system, and thus create a smooth transition to the menopausal period.

Other: Foot massage

Control group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Foot massage is applied in the form of pressure, rubbing and stimulation with special hand and finger techniques to reflex - warning points corresponding to all regions, organs and systems in the body. It is applied by applying pressure to all reflex points in the area from the toes to the ankles. In the study, a quiet and comfortable environment will be prepared at a room temperature of approximately 23-26 0C, and techniques that reveal the relaxing and calming effect of the massage will be selected. Thumb compression, slapping, patting, rubbing and squeezing movements are planned to be applied for a total of 20 minutes, 10 minutes on each foot, at the same time every day for 7 days.

Also known as: Reflexology
Foot massage

Eligibility Criteria

Age53 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 53-60 years who have gone through natural or surgical menopause
  • Women who can read and write.
  • Turkish-speaking women.

You may not qualify if:

  • Do not be diagnosed with any mental illness.
  • Existence of a situation that prevents foot massage application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Midwifery, Faculty of Health Sciences Inonu University

Malatya, Battalgazi, Turkey (Türkiye)

Location

Related Publications (1)

  • Gozuyesil E, Baser M. The effect of foot reflexology applied to women aged between 40 and 60 on vasomotor complaints and quality of life. Complement Ther Clin Pract. 2016 Aug;24:78-85. doi: 10.1016/j.ctcp.2016.05.011. Epub 2016 May 24.

    PMID: 27502805BACKGROUND

Related Links

MeSH Terms

Conditions

FatigueAnxiety Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Nilay GÖKBULUT

    Department of Midwifery, Faculty of Health Sciences, Çankırı Karatekin University

    PRINCIPAL INVESTIGATOR
  • Emine İBİCİ AKÇA

    Department of Midwifery, Faculty of Health Sciences, Amasya University,

    PRINCIPAL INVESTIGATOR
  • Çiğdem KARAKAYALI AY

    Department of Midwifery, Faculty of Health Sciences, Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 28, 2022

Study Start

November 1, 2021

Primary Completion

November 14, 2021

Study Completion

November 30, 2021

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.

Locations