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NCT Number: NCT04125355

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

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.

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Key information

Conditions

Sleep Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine Hospital

Izmir, 35000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • care to cancer patients at least for 6 months

Exclusion criteria

  • decline to participate in study

Treatment and study plan

Reflexology

Other

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

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.

Other names: plasebo

Primary outcomes

  1. Sleep

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2019
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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