DepressionNCT06411652
The Effect of Foot Reflexology and Therapeutic Touch on Fatigue, Depression and Quality of Sexual Life in Women
A study testing Reflexology and Therapeutic Touch in people with Depression, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This 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. Hemodialysis treatment may have negative effects on the quality of sexual life and mental health of female patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Reflexology and Therapeutic Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2024to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being sexually active
- Volunteering to participate in the research
Who cannot join
- The patient is 65 years or older or under 18 years of age
- Having a communication problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Reflexology and Therapeutic Touch on Fatigue, Depression and Quality of Sexual Life in Women Receiving Hemodialysis Treatment
This 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. Hemodialysis treatment may have negative effects on the quality of sexual life and mental health of female patients. In this context, understanding the potential healing effects of foot reflexology and therapeutic touch on sexual health and fatigue and depression in these individuals may contribute to the development of more effective support and treatment strategies.
Read the 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.
- Conditions
- Depression
- Being tested
- Reflexology, Therapeutic Touch
- Keywords
- Women Health
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
- First, the patient's foot will be cleaned with cotton dipped in warm water,
- In order not to disturb the patient, the hands will be warmed and one or two ccs of baby oil will be used to facilitate the massage.
- Before applying the main technique, the first two minutes of each session will be spent using the relaxation technique, which involves back and forth movements with the palm of the palm on the outer edge of the foot, from the outer part of the ankle to the little toe, to relieve muscle tension and spasm.
- Then, alternate pressure will be applied to the reflex points of the right thumb by taking the heel of one foot in the left hand.
Therapeutic TouchOther
- The procedure will be explained to the woman,
- The procedure will be performed in the patient's bed.
- The practitioner will center by making his body, mind and emotions quiet and focused, prepare himself for the practice and remain centered throughout the intervention,
- There will be good intentions to help the woman get treatment,
- In order to scan the energy field, the patient's entire body will be held with the palms of the practitioner's hands facing the patient, it will be moved with a soft movement from
| Study group | Role | What they receive |
|---|---|---|
| Reflexology Group | Experimental | 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. Receives: Other: Reflexology |
| Therapeutic Touch Group | Experimental | 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. Receives: Other: Therapeutic Touch |
| Control group | No intervention | No intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Quality of Life Scale-Female
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. It is accepted that as the score obtained from the scale increases, the individual's quality of sexual life also increases.
Measured: Four Weeks
Secondary outcomes (2)
Fatigue Severity Scale
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.
Measured: Four Weeks
Beck Depression Scale
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.
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start27 Feb 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental model with pretest posttest control group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANSU AĞRALI, Osmaniye Korkut Ata University
- Investigators
- Cansu Ağralı, Study director, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411652
- Sponsor's protocol ID
- OsmaniyeKAU-SBF-CA-02
- Status last verified
- Jul 2025
- First submitted
- 8 May 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology and Therapeutic Touch on Fatigue, Depression and Quality of Sexual Life in Women Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT06411652
- Acronym / sponsor ID
- OsmaniyeKAU-SBF-CA-02
- Conditions
- Depression
- Keywords
- Women Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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. Hemodialysis treatment may have negative effects on the quality of sexual life and mental health of female patients. In this context, understanding the potential healing effects of foot reflexology and therapeutic touch on sexual health and fatigue and depression in these individuals may contribute to the development of more effective support and treatment strategies.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental model with pretest posttest control group
| Arm | Type | Receives |
|---|---|---|
| Reflexology Group | Experimental | Other: ReflexologyThe 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. |
| Therapeutic Touch Group | Experimental | Other: Therapeutic TouchIn 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. |
| Control group | No intervention | –No intervention will be made. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being sexually active
- Volunteering to participate in the research
Key exclusion criteria (2 listed)
- The patient is 65 years or older or under 18 years of age
- Having a communication problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflexology1. First, the patient's foot will be cleaned with cotton dipped in warm water, 2. In order not to disturb the patient, the hands will be warmed and one or two ccs of baby oil will be used to facilitate the massage. 3. Before applying the main technique, the first two minutes of each session will be spent using the relaxation technique, which involves back and forth movements with the palm of the palm on the outer edge of the foot, from the outer part of the ankle to the little toe, to relieve muscle tension and spasm. 4. Then, alternate pressure will be applied to the reflex points of the right thumb by taking the heel of one foot in the left hand. | Other | Reflexology Group |
| Therapeutic Touch1. The procedure will be explained to the woman, 2. The procedure will be performed in the patient's bed. 3. The practitioner will center by making his body, mind and emotions quiet and focused, prepare himself for the practice and remain centered throughout the intervention, 4. There will be good intentions to help the woman get treatment, 5. In order to scan the energy field, the patient's entire body will be held with the palms of the practitioner's hands facing the patient, it will be moved with a soft movement from | Other | Therapeutic Touch Group |
Primary outcome
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. It is accepted that as the score obtained from the scale increases, the individual's quality of sexual life also increases.
2 secondary outcomes
Fatigue Severity Scale
Time frame: Four Weeks
Beck Depression Scale
Time frame: Four Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cansu Ağralı study director
Osmaniye Korkut Ata University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology and Therapeutic Touch in people with Depression, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Quality of Life Scale-Female (time frame: Four Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.