Care to Caregiver: The Effect of Reflexology on Sleep and... | NCT04125355

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

NCT04125355

Sponsor

Ege University

Status

Completed

Last Update Posted

Sep 7, 2023Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Sleep
Anxiety

Interventions

Reflexology
Placebo

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Sep 30, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2023

Last Update Posted Date

Sep 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

İsmail TOYGAR, Research Assistant, Ege UniversityPrincipal Investigator

Lead Sponsor

Ege UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo control	Other: Placebo
Reflexology	Experimental	foot reflexology	Other: Reflexology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reflexology	Other	Foot reflexology massage for 3 consecutive days and 60 minutes per day.	Reflexology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

care to cancer patients at least for 6 months

Exclusion Criteria:

decline to participate in study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
İsmail TOYGAR, Ph.D.	Ege University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University Faculty of Medicine Hospital		Izmir		35000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

undecided for now

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026201	Musculoskeletal Manipulations

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided