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

NCT04125355 | Completed

• 1 other identifier: EgeHemsirelik
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo control

Other: Placebo

Reflexology

EXPERIMENTAL

foot reflexology

Other: Reflexology

Interventions

Reflexology OTHER

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

Reflexology

Placebo OTHER

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

Also known as: plasebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• care to cancer patients at least for 6 months

You may not qualify if:

• decline to participate in study

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine Hospital

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• İsmail TOYGAR, Ph.D.

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 14, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)