- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06411652
The Effect of Foot Reflexology and Therapeutic Touch on Fatigue, Depression and Quality of Sexual Life in Women
The Effect of Foot Reflexology and Therapeutic Touch on Fatigue, Depression and Quality of Sexual Life in Women Receiving Hemodialysis Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic kidney disease (CKD) stands out as a rapidly increasing important health problem globally. CKD is a universal public health priority associated with significantly higher morbidity and mortality and excessive health care costs. The most common form of renal replacement therapy is hemodialysis. In patients with chronic kidney disease treated with hemodialysis, the disappearance of the survival advantage of women over men in the general population deeply affects the life experience of women. Among the additional difficulties that women face in this process compared to men, the inability to maintain their emotional resilience, failure to comply with treatment, and failure to meet their social support needs come to the fore.
The problems caused by hemodialysis and chronic illness create a significant burden on women, both materially and spiritually, and negatively affect women's quality of life. Common and common conditions include sleep disorders, fatigue, depression and pain. In addition, higher levels of sexual dysfunction have been reported in women with hemodialysis, and it has been stated that loss of sexuality may reduce self-confidence and cause problems in marriage. Chronic hemodialysis patients, especially female patients, should be supported in terms of sexual dysfunctions and psychosocial conditions. Therefore, health professionals should evaluate the psychosocial lives of especially female patients and provide the necessary support. Health professionals' use of complementary approaches to reduce patients' problems and improve their negative emotional states increases the effectiveness of medical treatment.
Reflexology and therapeutic touch are among the low-cost and complication-free nursing interventions. These nursing interventions can be used together with medical treatments to reduce stress and balance the body. Studies indicate that reflexology application and therapeutic touch can be effective in improving sexual function and positive emotions. However, when the literature is examined, it is observed that there are no studies evaluating therapeutic touch intervention in women receiving hemodialysis treatment, and reflexology studies are quite inadequate. Therefore, our study aims to examine the effects of foot reflexology and therapeutic touch on fatigue, depression and sexual quality of life in women receiving hemodialysis treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cansu AĞRALI
- Phone Number: 05317461333
- Email: agralicansu9@gmail.com
Study Contact Backup
- Name: Cansu AĞRALI
Study Locations
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Osmaniye, Turkey, 80000
- Recruiting
- Osmaniye New State Hospital
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Contact:
- Osmaniye New State Hospital
- Phone Number: (0328) 816 84 00
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Principal Investigator:
- Cansu AĞRALI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being sexually active
- Volunteering to participate in the research
Exclusion Criteria:
- The patient is 65 years or older or under 18 years of age
- Having a communication problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reflexology Group
The researcher has received a practitioner reflexology certificate.
The researcher will begin the massage during the second hour of dialysis, as the patient's condition is more stable and the unit is less crowded due to routine care.
Before the intervention, the patient's privacy will be protected in the reflexology group; The researcher will sit in a chair at the foot of the patient's bed and perform a reflexology massage.
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Experimental: Therapeutic Touch Group
In order to perform Therapeutic Touch application, the researcher attended the first level training prepared by the International Therapeutic Touch Association and received a certificate.
For therapeutic touch application, the researcher will start the application in the second hour of dialysis, as the patient's condition is more stable and the unit is less crowded due to routine care.
Therapeutic touch application will be applied to women in the hemodialysis care unit, twice a week for four weeks, for a total of 8 sessions, each lasting 15 minutes.
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No Intervention: Control group
No intervention will be made.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Quality of Life Scale-Female
Time Frame: Four Weeks
|
Sexual Quality of Life Scale, Symonds et al.
It is a scale whose validity and reliability have been established by.
The scale is a scale that can be applied to all women over the age of 18, but the validity and reliability study of the original scale was conducted on women in the 18-65 age group.
The scale is easy to apply, six-point Likert type, and consists of 18 items that individuals can answer on their own.
Each item is expected to be answered considering your sexual life in the last four weeks.
In the original version of the scale, it is stated that each item can be scored between 1-6 or 0-5.
In this study, a 1-6 point system (1 = Completely agree, 2 = Largely agree, 3 = Partially agree, 4 = Partially disagree, 5 = Largely disagree, 6 = Strongly disagree) was used.
In this way, the score range that can be obtained from the scale is between 18-108.
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Four Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Severity Scale
Time Frame: Four Weeks
|
The Fatigue Severity Scale, developed by Krup, is a scale consisting of nine items that evaluates the general impact of fatigue on daily activities.
The Turkish validity and reliability of the scale was determined by Armutlu et al.
Made by.
In the scale, individuals are asked to rate the fatigue they felt throughout the past week on a scale from 1 to 7. Each section is scored between 1 (completely disagree) and 7 (completely agree).
The total score is calculated by taking the average of nine items.
The cut-off value for pathological fatigue was determined as 4 and above.
The lower the total score, the less fatigue.
Armutlu et al.
In the study, it was stated that the Cronbach's alpha coefficient of the scale was 0.94.
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Four Weeks
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Beck Depression Scale
Time Frame: Four Weeks
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This scale, which was first developed by Aaron T. Beck (1961), was adapted into Turkish in 1988 and its validity and reliability were checked by Hisli.
Beck 21 depression scale consists of 21 items and each of these items has four options.
Each item receives a score between 0 and 3, and a depression score is obtained by summing these scores.
The highest total score that can be obtained is 63, and a high score indicates the severity of depression.
The cut-off score was taken as 17.
Those who scored 17 or more were considered to have symptoms of depression.
In the validity and reliability study of BDI, the Cronbach α reliability coefficient was determined as 0.80.
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Four Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cansu Ağralı, Osmaniye Korkut Ata University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OsmaniyeKAU-SBF-CA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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