The Impact of Relaxation Massage Before Bedtime on Sleep Quality and Quantity.

NCT06781866 | Completed

• 1 other identifier: 2334-3/4-2/7.2.2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Manual massage is an effective treatment approach for reducing general stress and promoting an overall sense of wellbeing. Relaxation massage aims to alleviate psychophysiological tension, enhance both blood and lymphatic circulation, and promote mental and physical relaxation. It is particularly beneficial for those with anxiety-related symptoms (such as generalized anxiety dis-order, social anxiety) and sleep disorders, aiming to improve calmness and promote sleepiness. The purpose of the present study is to assess the effectiveness of a single session of relaxation massage prior to bed-time on sleep quality and quantity indices, in individuals with symptoms of chronic insomnia.

Conditions

Massage

Keywords

Relaxation Massage; Manual Massage Therapy; Insomnia

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  Total sleep time over Time spend in bed

  9 hours

Secondary Outcomes (1)

• Sustained Sleep Efficiency

  9 hours

Study Arms (3)

Control

NO INTERVENTION

For the control (CON) session participants will not receive any massage session and they will follow their usual bedtime routine.

Relaxation Massage

EXPERIMENTAL

For the relaxation massage (REL) session, participants will receive a massage session lasting for 45 minutes before bedtime and they will instructed to follow their usual bedtime routine

Other: Massage

Sham Massage

SHAM COMPARATOR

For the sham" massage (PLA) session, participants will receive a sham-massage session (full body oil rubbing) lasting for 45 minutes before bedtime and they will instructed to follow their usual bedtime routine

Other: Sham (No Treatment)

Interventions

Massage OTHER

A relaxation type of massage will be used as the main massage intervention in this study. This technique is designed to promote deep relaxation, reduce stress, and enhance overall well-being. It is characterized by the use of five primary techniques performed on the full body, including the palms and feet. Specifically, these techniques consist of effleurage (long, gliding strokes), petrissage (kneading and squeezing), tapotement (rhythmic tapping), friction (deep, circular rubbing), and vibration or shaking movements (Table 1). In addition to these, the technique also incorporates rhythmic movements and deep light pressure to enhance relaxation and alleviate tension. It is designed to promote relaxation, increase blood circulation, relieve muscle tension, improve flexibility and promote relaxation and reduce pain. The total duration of the Relaxation massage is 45 minutes.

Relaxation Massage

Sham (No Treatment) OTHER

The Sham massage (PLA) will be used as a control session, without applying the deeper techniques that characterize the Relaxation massage in order to eliminate the influence of the human touch sensation on the participant's skin. This massage consisted only of superficial oil application movements over the entire body, without any added pressure or deep muscle manipulation. Oil was used to facilitate smooth gliding, mimicking the sensation of a full massage, but without the intensity or techniques aimed at muscle tissue relaxation. The total duration of the sham massage is 45 minutes.

Sham Massage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Sex assigned at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• score of ≥16 on the Athens Insomnia Scale (AIS-8)

You may not qualify if:

• history of mental illness, dermatological diseases, allergies to massage oil and any acute or chronic condition that would limit the ability of the patient to participate or consent in the study

Sponsors & Collaborators

• University of Thessaly: lead
• University of Nicosia: collaborator

Study Sites (1)

School of Physical Education, Sports and Dietetics, TEFAA

Trikala, Thessaly, GR42100, Greece

Location

Related Publications (3)

• Mai E, Buysse DJ. Insomnia: Prevalence, Impact, Pathogenesis, Differential Diagnosis, and Evaluation. Sleep Med Clin. 2008;3(2):167-174. doi: 10.1016/j.jsmc.2008.02.001. No abstract available.

  PMID: 19122760 BACKGROUND

• Buyukyilmaz F, Asti T. The effect of relaxation techniques and back massage on pain and anxiety in Turkish total hip or knee arthroplasty patients. Pain Manag Nurs. 2013 Sep;14(3):143-54. doi: 10.1016/j.pmn.2010.11.001. Epub 2011 Jan 28.

  PMID: 23972865 BACKGROUND

• Ntoumas I, Karatzaferi C, Giannaki CD, Papanikolaou F, Pappas A, Dardiotis E, Sakkas GK. The Impact of Relaxation Massage Prior to Bedtime on Sleep Quality and Quantity in People with Symptoms of Chronic Insomnia: A Home-Based Sleep Study. Healthcare (Basel). 2025 Jan 17;13(2):180. doi: 10.3390/healthcare13020180.

  PMID: 39857207 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Massage; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Giorgos Sakkas, 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 13, 2025
• First Posted: January 17, 2025
• Study Start: September 9, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 10, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 01/01/2025 - 01/01/2026
• Access Criteria: Written request to the PI

Locations

GR (1)