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Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT04125355
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
4
Actual Duration (Months)
15.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Reflexology
  • Other: Placebo
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Care to Caregiver: The Effect of Reflexology on Sleep and Anxiety of Cancer Caregiver
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo control

Other: 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.
Other Names:
  • plasebo

    		•
    Experimental: Reflexology

    foot reflexology

    Other: Reflexology
    Foot reflexology massage for 3 consecutive days and 60 minutes per day.

    Outcome Measures

    Primary Outcome Measures

    1. Sleep [3 day]

      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

    2. Anxiety [3 day]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • care to cancer patients at least for 6 months
    Exclusion Criteria:
    • decline to participate in study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ege University Faculty of Medicine Hospital İzmir Turkey 35000

    Sponsors and Collaborators

    • Ege University

    Investigators

    • Study Director: İsmail TOYGAR, Ph.D., Ege University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    İsmail TOYGAR, Research Assistant, Ege University
    ClinicalTrials.gov Identifier:
    NCT04125355
    Other Study ID Numbers:
    • EgeHemsirelik
    First Posted:
    Oct 14, 2019
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Oct 15, 2019