NCT06411652

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

May 8, 2024

Last Update Submit

July 28, 2025

Conditions

Keywords

Women Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Four Weeks

Secondary Outcomes (2)

  • Fatigue Severity Scale

    Four Weeks

  • Beck Depression Scale

    Four Weeks

Study Arms (3)

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.

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.

Other: Therapeutic Touch

Control group

NO INTERVENTION

No intervention will be made.

Interventions

1. 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.

Reflexology Group

1. 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

Therapeutic Touch Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being sexually active
  • Volunteering to participate in the research

You may not qualify if:

  • The patient is 65 years or older or under 18 years of age
  • Having a communication problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye New State Hospital

Osmaniye, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Interventions

Musculoskeletal ManipulationsTherapeutic Touch

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body TherapiesSpiritual Therapies

Study Officials

  • Cansu Ağralı

    Osmaniye Korkut Ata University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental model with pretest posttest control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant at the Midwifery Department of the Faculty of Health Sciences

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 13, 2024

Study Start

February 27, 2024

Primary Completion

September 27, 2024

Study Completion

September 27, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations