NCT06784700

Brief Summary

Modern technology is transforming the field of massage, enhancing relaxation and wellness through innovative devices. The automatic electric massage chair exemplifies this advancement, merging ergonomic design with advanced massage techniques to promote deep tissue relaxation and an overall sense of well-being. The purpose of the present study is to examine the effectiveness of various automatic massage protocols available in massage chairs on relaxation and indices of sleep quality in healthy individuals before daytime naps.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 14, 2025

Last Update Submit

January 22, 2025

Conditions

Sleep QualityRelaxation

Keywords

insomniamassagemassage chairsleep efficiencywellness

Outcome Measures

Primary Outcomes (1)

  • Sleep Efficiency

    Total sleep time over Time spend in bed.

    60 minutes - at the end of the intervention

Secondary Outcomes (1)

  • Sleepiness

    At baseline and at the end of the intervention (60 minutes).

Study Arms (4)

Control

SHAM COMPARATOR

The Control (CON) condition involves a 30-minute rest on a switch-off massage chair (without running any massage session).

Other: No intervention

Easy-Sleep

EXPERIMENTAL

The Easy Sleep (ES) automatic massage condition involves a 30-minute inside the massage chair receiving a relaxation massage designed to promote sleep.

Other: Massage

Fatigue-Recovery

EXPERIMENTAL

The Fatigue Recovery (FR) automatic massage condition involves a 30-minute inside the massage chair receiving a relaxation massage designed to reduce muscle fatigue.

Other: Massage

Worker-Mode

EXPERIMENTAL

The Worker Mode (WM) automatic massage condition involves a 30-minute inside the massage chair receiving a relaxation massage designed to promote muscle relaxation.

Other: Massage

Interventions

MassageOTHER

Participants will be positioned inside a massage chair for a 30-min, followed by an additional 30-minute period of lying down on a proper double bed.

Easy-SleepFatigue-RecoveryWorker-Mode
No interventionOTHER

Subjects will not receive any massage program; instead, they will be rested for 30 minutes on an automatic switch-off electric massage chair and subsequently lay down for an additional 30 minutes on a proper double bed;

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbiological sex at birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ability to consent

You may not qualify if:

  • history of mental illness,
  • sleep disorders,
  • history of epilepsy,
  • an acute or chronic condition that would limit the ability of the patient to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education, Sports and Dietetics, TEFAA

Trikala, Thessaly, 42100, Greece

Location

Related Publications (3)

  • Fu M, Sun C, Liu T, Li S. EFFECT OF MASSOTHERAPY ON THE FATIGUE RECOVERY USING THE SMART MASSAGE CHAIR: A RANDOMIZED CONTROLLED TRIAL. J Mech Med Biol. 2022;22(9). doi:10.1142/S0219519422400462

    BACKGROUND

  • Kim YJ, Kim HR, Jung YH, Park YH, Seo SW. Effects of Electrical Automatic Massage on Cognition and Sleep Quality in Alzheimer's Disease Spectrum Patients: A Randomized Controlled Trial. Yonsei Med J. 2021 Aug;62(8):717-725. doi: 10.3349/ymj.2021.62.8.717.

    PMID: 34296549BACKGROUND

  • Ntoumas I, Antoniou N, Giannaki CD, Papanikolaou F, Pappas A, Dardiotis E, Karatzaferi C, Sakkas GK. New Generation Automatic Massage Chairs for Enhancing Daytime Naps: A Crossover Placebo-Controlled Trial. Healthcare (Basel). 2025 Sep 12;13(18):2291. doi: 10.3390/healthcare13182291.

    PMID: 41008423DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Christina Karatzaferi, PhD

    University of Thessaly

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

March 4, 2024

Primary Completion

August 23, 2024

Study Completion

December 13, 2024

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Jan 2025 - Jan 2026
Access Criteria
Requested by email from the PI

Locations

GR(1)