Foot Massage for Women With Menopause

Menopausal Women Clinical Trial

Official title:

The Impact of Foot Massage Applied to Menopausal Women on Anxiety, Fatigue and Sleep Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212376
• Other study ID #: 2021/2497
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: June 2022
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 30, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 53 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopausal Women

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Department of Midwifery, Faculty of Health Sciences Inonu University	Malatya	Battalgazi

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatigue level in women with menopause	The scales consist of 9 items. Each item is scored as "1=Strongly disagree, 2= Disagree, 3=Tend not to agree, 4=Hesitant, 5=Tend to disagree, 6=Agree, 7=Definitely agree". The person is asked to select the option that suits them best. The total score is found by the average of 9 questions. A high score indicates an increased degree of fatigue.	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	Anxiety level in women with menopause	BAI consists of a total of 21 items. The inventory is 4-point Likert type and each item is scored as "0 =None, 1 =Mild, 2 =Moderate, 3 =Severe". A minimum of 0 and a maximum of 63 points can be obtained from the inventory. An increase in the scores obtained from the inventory indicates that the level of anxiety also increases.	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.

External Links

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