MassageGoodnightTouchNCT06781866
The Impact of Relaxation Massage Before Bedtime on Sleep Quality and Quantity.
A study testing Massage in people with Massage, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Massage
- What is being tested?
- Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 9 Sep 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- score of ≥16 on the Athens Insomnia Scale (AIS-8)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Physical Education, Sports and Dietetics, TEFAA
Trikala, Thessaly, GR42100
About this study
Official title: The Impact of Relaxation Massage Prior to Bed-time on Sleep Quality and Quantity in People with Symptoms of Chronic In-somnia: a Home-Based Sleep Study.
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.
Read the detailed description
Study Design:
The current study will assess the impact of an in-house full-body deep relaxation massage session performed by a professional masseur in objective measurements of sleep quality and quantity in participants suffering from chronic insomnia just before they go to bed.
The volunteers of the current study will participate in 3 different scenarios, each 5 days apart: Scenario 1 is the control session when participants' sleep will be recorded without any massage intervention. Participants will follow their usual bed-time routine.
Scenario 2, participants will receive a deep relaxation massage session lasting 40 min and follow the sleep recording set up before they follow their usual bedtime routine.
Scenario 3, participants will receive a placebo massage session lasting 40 min (oil rubbing application in participants' body places similar to the massage session) and followed by the sleep recording set up before they follow their usual bedtime routine.
Scenarios 2 and 3 take place in random order for every participant.
Methodology The individuals who are suffering from chronic insomnia and scored more than 15 in the Athens Insomnia Scale, will be the target group. All participants will sign an informed consent form in order to participate in the study. The study is approved by the University's Internal Ethics Committee.
Demographic Characteristics: Demographic characteristics include age, gender, race/ethnicity.
Questionnaires Quality of sleep: The Athens Insomnia Scale, Weekly sleep diary and Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality and sleep abnormalities.
Relaxation symptoms: The Relaxation State Questionnaire (RSQ) will be used for the assessment of relaxation symptoms.
Quality of life: The SF36QoL questionnaire (SF-36) will be used for the assessment of the levels of quality of life.
Depressive symptoms: The Beck Depression Inventory (BDI) questionnaire will be used for the assessment of depressive symptoms and signs.
Stress: The STATE - TRAIT ANXIETY INVENTORY (STAI) will be used for the assessment of stress levels.
Sleep Quality Assessment: Quality and quantity of sleep will be assessed by an overnight Home Sleep Test (HST) (SOMNOmedics). Specifically, HST records your brain waves, head movement, body position and snore rhythm during the study.
Massage Intervention Relaxation Massage This technique will be performed all over the body. Exclusively, on specific leg muscle groups such as the gastrocnemius, the femoral biceps and quadriceps and in upper body muscle groups such as the triceps, the rhomboid, the deltoid, the trapezius and head areas. We applied slow strokes and deep finger pressure to ease away pain from the deepest layers of their muscles and connective tissues. The total duration of the relaxation massage will be 35-40 minutes.
Procedure Individuals who achieve a score above 15 (on a scale of 1-24 points) and meet all required conditions will participate in the study.
All procedures will be performed in three visits, one week apart (weekly), and take place at each subject's home:
At the first visit, the Home Sleep Test (HST) we will used to conduct an 8 hour overnight sleep recording.
A daily sleep questionnaire will be handed to the participant to fill out for the next 5 consecutive days.
Also, Relaxation State Questionnaire (RSQ) will be handed to the participant to fill out before and after massage protocol.
On the second and third visit, the same process will be repeated.
Statistical Analysis The statistical analysis will be performed using IBM SPSS Statistics version 29.0 (IBM Corporation, Armonk NY, USA). An independent samples t-Test will be used to assess significant differences in basic characteristics between male and female participants. A General Linear Model-Repeated Measures will be used to examine if there are significant differences in the sleep parameters and sleep diary data between the 3 sessions. To assess normality, the Shapiro-Wilk test will be used alongside graphical repre-sentations, including the Normal Q-Q plot, Detrended Normal Q-Q plot, and Box Plot. The significance level is set at 5%. Beyond significance testing (p-value), effect size is also going to be considered to evaluate the magnitude of the effect.
Power Analysis Sample size calculations were conducted using G*Power 3.1.[36] The post-hoc "GLM: Repeated measures, within factors" method was used for the power analysis. Based on an expected medium effect size of 0.25 (Cohen's f), a significance level of α = 0.05, and a desired power (1-β) of 0.82 (82%), the resulting minimum required sample size was calculated to be 20 participants. The critical F-value was 3.16 with (Ndf) = 2 and (Ddf) = 54.
- Conditions
- Massage
- Being tested
- Massage, Sham (No Treatment)
- Keywords
- Relaxation Massage, Manual Massage Therapy, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Total sleep time over Time spend in bed
Measured: 9 hours
Secondary outcomes (1)
Sustained Sleep Efficiency
Total sleep time/(Time in bed - Sleep latency stage)
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start9 Sep 2024
- Primary completion6 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MassageStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nicosia
- Responsible party
- Principal investigator, Giorgos K. Sakkas, University of Thessaly
- Investigators
- Giorgos Sakkas, PhD, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781866
- Sponsor's protocol ID
- 2334-3/4-2/7.2.2024
- Acronym
- GoodnightTouch
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Full data set, IRB protocol, consent form
Publications
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.
PubMed 19122760Buyukyilmaz 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.
PubMed 23972865Ntoumas 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.
PubMed 39857207
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Relaxation Massage Prior to Bed-time on Sleep Quality and Quantity in People with Symptoms of Chronic In-somnia: a Home-Based Sleep Study.
- ClinicalTrials.gov ID
- NCT06781866
- Acronym / sponsor ID
- GoodnightTouch / 2334-3/4-2/7.2.2024
- Conditions
- Massage
- Keywords
- Relaxation Massage, Manual Massage Therapy, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Nicosia
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
The current study will assess the impact of an in-house full-body deep relaxation massage session performed by a professional masseur in objective measurements of sleep quality and quantity in participants suffering from chronic insomnia just before they go to bed.
The volunteers of the current study will participate in 3 different scenarios, each 5 days apart: Scenario 1 is the control session when participants' sleep will be recorded without any massage intervention. Participants will follow their usual bed-time routine.
Scenario 2, participants will receive a deep relaxation massage session lasting 40 min and follow the sleep recording set up before they follow their usual bedtime routine.
Scenario 3, participants will receive a placebo massage session lasting 40 min (oil rubbing application in participants' body places similar to the massage session) and followed by the sleep recording set up before they follow their usual bedtime routine.
Scenarios 2 and 3 take place in random order for every participant.
Methodology The individuals who are suffering from chronic insomnia and scored more than 15 in the Athens Insomnia Scale, will be the target group. All participants will sign an informed consent form in order to participate in the study. The study is approved by the University's Internal Ethics Committee.
Demographic Characteristics: Demographic characteristics include age, gender, race/ethnicity.
Questionnaires Quality of sleep: The Athens Insomnia Scale, Weekly sleep diary and Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality and sleep abnormalities.
Relaxation symptoms: The Relaxation State Questionnaire (RSQ) will be used for the assessment of relaxation symptoms.
Quality of life: The SF36QoL questionnaire (SF-36) will be used for the assessment of the levels of quality of life.
Depressive symptoms: The Beck Depression Inventory (BDI) questionnaire will be used for the assessment of depressive symptoms and signs.
Stress: The STATE - TRAIT ANXIETY INVENTORY (STAI) will be used for the assessment of stress levels.
Sleep Quality Assessment: Quality and quantity of sleep will be assessed by an overnight Home Sleep Test (HST) (SOMNOmedics). Specifically, HST records your brain waves, head movement, body position and snore rhythm during the study.
Massage Intervention Relaxation Massage This technique will be performed all over the body. Exclusively, on specific leg muscle groups such as the gastrocnemius, the femoral biceps and quadriceps and in upper body muscle groups such as the triceps, the rhomboid, the deltoid, the trapezius and head areas. We applied slow strokes and deep finger pressure to ease away pain from the deepest layers of their muscles and connective tissues. The total duration of the relaxation massage will be 35-40 minutes.
Procedure Individuals who achieve a score above 15 (on a scale of 1-24 points) and meet all required conditions will participate in the study.
All procedures will be performed in three visits, one week apart (weekly), and take place at each subject's home:
At the first visit, the Home Sleep Test (HST) we will used to conduct an 8 hour overnight sleep recording.
A daily sleep questionnaire will be handed to the participant to fill out for the next 5 consecutive days.
Also, Relaxation State Questionnaire (RSQ) will be handed to the participant to fill out before and after massage protocol.
On the second and third visit, the same process will be repeated.
Statistical Analysis The statistical analysis will be performed using IBM SPSS Statistics version 29.0 (IBM Corporation, Armonk NY, USA). An independent samples t-Test will be used to assess significant differences in basic characteristics between male and female participants. A General Linear Model-Repeated Measures will be used to examine if there are significant differences in the sleep parameters and sleep diary data between the 3 sessions. To assess normality, the Shapiro-Wilk test will be used alongside graphical repre-sentations, including the Normal Q-Q plot, Detrended Normal Q-Q plot, and Box Plot. The significance level is set at 5%. Beyond significance testing (p-value), effect size is also going to be considered to evaluate the magnitude of the effect.
Power Analysis Sample size calculations were conducted using G*Power 3.1.[36] The post-hoc "GLM: Repeated measures, within factors" method was used for the power analysis. Based on an expected medium effect size of 0.25 (Cohen's f), a significance level of α = 0.05, and a desired power (1-β) of 0.82 (82%), the resulting minimum required sample size was calculated to be 20 participants. The critical F-value was 3.16 with (Ndf) = 2 and (Ddf) = 54.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: MassageFor 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 |
| Sham Massage | Sham comparator | Other: Sham (No Treatment)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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- score of ≥16 on the Athens Insomnia Scale (AIS-8)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageA 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. | Other | Relaxation Massage |
| Sham (No Treatment)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. | Other | Sham Massage |
Primary outcome
Sleep Efficiency
Time frame: 9 hours
Total sleep time over Time spend in bed
1 secondary outcome
Sustained Sleep Efficiency
Time frame: 9 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 19122760Mai 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.
- Background: PubMed 23972865Buyukyilmaz 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.
- Derived from this study: PubMed 39857207Ntoumas 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.
- Individual participant dataSharing planned: Yes. Full data set, IRB protocol, consent form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgos Sakkas, PhD study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Massage, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781866, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.