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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04125355
Other study ID # EgeHemsirelik
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date September 1, 2019

Study information

Verified date September 2023
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction and Aim: With the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. However, the problems experienced by individuals caring for cancer patients are often ignored. The most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. Although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. The aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers. Materials and Methods: The study was conducted as a double-blind placebo-controlled design. After the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands was moved around the foot for the same periods but no deep stimulation was applied. On the fourth day, a sociodemographic diagnostic form, state anxiety scale and Richard-Campbell Sleep Scale were administered to the participants by a blinded researcher. Data were analyzed with SPSS 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.


Description:

Introduction and Aim: With the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. However, the problems experienced by individuals caring for cancer patients are often ignored. The most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. Although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. The aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers. Materials and Methods: The study was conducted as a double-blind placebo-controlled design. After the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands were moved around the foot for the same periods but no deep stimulation was applied. On the fourth day, a sociodemographic diagnostic form, state anxiety scale, and Richard-Campbell Sleep Scale were administered to the participants by a blinded researcher. Data were analyzed with SPSS 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - care to cancer patients at least for 6 months Exclusion Criteria: - decline to participate in study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reflexology
Foot reflexology massage for 3 consecutive days and 60 minutes per day.
Placebo
Placebo for 3 consecutive days and 60 minutes per day. This intervention only include touch to the foot, it doesn't include deep stimulation.

Locations

Country Name City State
Turkey Ege University Faculty of Medicine Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Quality of sleep - richard campbell sleep questionnaire used to determine the quality of sleep of the patients. This questinairre used for both groups. The minimum total score in the scale is 0 and maximum is 600. The increase of the total score shows the increase the quality of sleep. the scale don't have any subscale 3 day
Primary Anxiety Level of Anxiety - The state anxiety inventory used to determine anxiety level of patients. This inventory used for both groups. The lowest total score of the scale is 20 and to highest is 80. the increase of the total points indicates the increase in anxiety. the scale don't have any subscale. 3 day
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