Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver
Primary Purpose
Sleep, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reflexology
Placebo
Sponsored by

About this trial
This is an interventional supportive care trial for Sleep
Eligibility Criteria
Inclusion Criteria:
- care to cancer patients at least for 6 months
Exclusion Criteria:
- decline to participate in study
Sites / Locations
- Ege University Faculty of Medicine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Reflexology
Arm Description
Placebo control
foot reflexology
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04125355
Brief Title
Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver
Official Title
Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo control
Arm Title
Reflexology
Arm Type
Experimental
Arm Description
foot reflexology
Intervention Type
Other
Intervention Name(s)
Reflexology
Intervention Description
Foot reflexology massage for 3 consecutive days and 60 minutes per day.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
plasebo
Intervention Description
Placebo for 3 consecutive days and 60 minutes per day. This intervention only include touch to the foot, it doesn't include deep stimulation.
Primary Outcome Measure Information:
Title
Sleep
Description
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
Time Frame
3 day
Title
Anxiety
Description
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.
Time Frame
3 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
care to cancer patients at least for 6 months
Exclusion Criteria:
decline to participate in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail TOYGAR, Ph.D.
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Ege University Faculty of Medicine Hospital
City
İzmir
ZIP/Postal Code
35000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
undecided for now
Learn more about this trial
Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver
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