Foot Massage for Women With Menopause

NCT ID: NCT05212376

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2021-11-30

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.

Detailed Description

The population of the study was planned to be composed of menopausal women residing in a village in the north of Turkey. Menopausal women residing in the village were reached from the records of the health unit of the participants. The number of people to be included in the sample of the study was determined by power analysis. G*power 3.1.9.2 program was used in the study. According to the calculations made, the minimum sample size of the study was 0.40, the error level was 0.05, and the population representativeness was 0.95 to 64 women (32 experiment, 32 control). Considering the possible data losses (10%), 70 women (35 experimental, 35 control) were planned to be included in the study. It was planned to include women who are literate, open to communication, and have naturally entered menopause in the last 1 year. The data are planned to be collected by the researchers through face-to-face interviews at the homes of menopausal women residing in a village in northern Turkey between 01-30 November 2021.

Experimental group Menopausal women in the experimental group will be met at the first interview at their home, the participants will be informed about the method and their written consent will be obtained. Pre-test data will be obtained by filling in the personal information form, "Fatigue Severity Scale" and "Beck Anxiety Inventory" before the foot massage. The same researcher will plan to give women a foot massage once a day for 7 days. It is anticipated that the foot massage application will take a total of 20 minutes on both feet. On the last day (7th day), 30 minutes after the foot massage, FSS and BAI will be applied again and the final test data will be obtained.

Control group Menopausal women in the control group will be met at the first interview at their homes, the participants will be informed about the method and their written consent will be obtained. It will be planned to obtain the pre-test data by filling in the "Fatigue Severity Scale" and "Beck Anxiety Inventory". No intervention will be applied to the women in the control group. A second home visit will be made one week after the pre-test data are received and the post-test data will be obtained.

The initiative will be implemented by an internationally certified research midwife academic (N.G.) after a training on foot massage (16 hours). It is planned to create a quiet and comfortable environment at a room temperature of approximately 23-26 C, and to choose techniques that reveal the relaxing and calming effect of the massage. Thumb pressure application, slapping, patting, rubbing and squeezing movements will be applied for a total of 20 minutes, 10 minutes on each foot, at the same time every day for 7 days.

To evaluate the fatigue and anxiety levels, pretest and posttest data will be obtained by applying FSS and BAI just before the first foot massage (day 1) and 30 minutes after the last foot massage (day 7).

Conditions

Menopausal Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Foot massage

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.

Group Type: EXPERIMENTAL

Foot massage

Intervention Type: OTHER

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.

Control group

No intervention will be applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Foot massage

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.

Intervention Type: OTHER

Other Intervention Names

Reflexology

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 53 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Çiğdem KARAKAYALI AY

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilay GÖKBULUT

Role: PRINCIPAL_INVESTIGATOR

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

Emine İBİCİ AKÇA

Role: PRINCIPAL_INVESTIGATOR

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

Çiğdem KARAKAYALI AY

Role: PRINCIPAL_INVESTIGATOR

Department of Midwifery, Faculty of Health Sciences, Inonu University

Locations

Department of Midwifery, Faculty of Health Sciences Inonu University

Malatya, Battalgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27502805 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/27502805/

The effect of foot reflexology applied to women aged between 40 and 60 on vasomotor complaints and quality of life

Other Identifiers

2021/2497

Identifier Type: -

Identifier Source: org_study_id