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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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05212376
Study type Interventional
Source Inonu University
Contact
Status Completed
Phase N/A
Start date November 1, 2021
Completion date November 30, 2021

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