- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272031
Office Massage Effects on HRV and Stress
Randomized Controlled Trial to Evaluate the Effectiveness of Three Different 15-Minute Office Massage Types (Head, Cervical Area, Hand) on Autonomic Nervous System Balance and Chronic Stress Reduction Using Heart Rate Variability (HRV)
This study is a randomized controlled trial designed to investigate which of three short office massage types (head, neck/shoulder area, or hand) is most effective for reducing chronic stress in women who perform sedentary office work.
Many sedentary female office employees experience long-term tension and work-related strain, which can affect the body's ability to recover. The investigators are testing whether a 15-minute massage, performed twice a week for four weeks, can help restore balance within the body.
The investigators will evaluate the impact of these massages using Heart Rate Variability (HRV)-an objective measure that shows how well the body manages stress (autonomic nervous system balance)-as well as analyzing participants' self-reported levels of perceived stress, sleep quality, and overall well-being. Participants receiving massage will be compared to a control group engaging in quiet rest.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Una Veseta, PhD
- Phone Number: +37129172627
- Email: una.veseta@rsu.lv
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Biological females aged 18 years or older. Currently working in an office job with at least 75% of the working day spent sitting (sedentary work).
Must report a regular menstrual cycle (cycle length 21-35 days) for at least the past 6 months.
Able to attend all scheduled intervention sessions (8 sessions over 4 weeks). Able to provide informed consent to participate in the study.
Exclusion Criteria:
Use of hormonal contraceptives or other hormone-containing therapies (e.g., Intrauterine Device (IUDs), patches, birth control pills).
Pregnancy, current breastfeeding, or planning pregnancy during the study period.
Menopause (natural or surgically induced). Diagnosis of a severe chronic disease (e.g., heart failure, insulin-dependent diabetes, diagnosed neurological disorder).
Active cancer or history of cancer within the last 5 years. Current diagnosis of a major psychiatric disorder (e.g., major depressive disorder, bipolar disorder).
Current use of psychotropic medications that could significantly affect Heart Rate Variability (HRV) (e.g., certain beta-blockers, anti-depressants).
History of recent surgery (within the last 3 months) in the neck or upper extremities.
Participation in another clinical trial simultaneously.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Head Massage
Duration and Frequency: 15 minutes per session, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Massage focuses on the scalp, temples, and auricles (outer ear) with the aim of stimulating cranial nerves, particularly branches of the vagus nerve.
The procedure is performed by a licensed massage therapist while the participant is seated in an office chair.
|
15 minutes per session, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Massage focuses on the scalp, temples, and auricles (outer ear) with the aim of stimulating cranial nerves, particularly branches of the vagus nerve.
The procedure is performed by a licensed massage therapist while the participant is seated in an office chair.
|
|
Active Comparator: Cervical Area Massage
Duration and Frequency: 15 minutes per session, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Deep tissue and kneading massage techniques applied primarily to the trapezius muscles, levator scapulae, and sub-occipital region (neck/shoulders).
The procedure is performed by a licensed massage therapist while the participant is seated in an office chair.
|
15 minutes per session, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Deep tissue and kneading massage techniques applied primarily to the trapezius muscles, levator scapulae, and sub-occipital region (neck/shoulders).
The procedure is performed by a licensed massage therapist while the participant is seated in an office chair.
|
|
Active Comparator: Hand Massage
Duration and Frequency: 15 minutes per session, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Compression, rubbing, and stroking techniques applied to the palmar and dorsal surfaces of the hands, fingers, and wrists.
The procedure is performed by a licensed massage therapist while the participant is seated in an office chair.
|
15 minutes per session, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Compression, rubbing, and stroking techniques applied to the palmar and dorsal surfaces of the hands, fingers, and wrists.
The procedure is performed by a licensed massage therapist while the participant is seated in an office chair.
|
|
Placebo Comparator: Quiet Rest Control
Duration and Frequency: Participants are seated in the same office chair for a structured 15-minute period, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Participants are instructed to sit quietly, avoid work-related activity, and refrain from using electronic devices.
This arm controls for the effect of researcher attention and time spent away from work.
|
Participants are seated in the same office chair for a structured 15-minute period, 2 times per week for 4 consecutive weeks (8 sessions total).
Focus: Participants are instructed to sit quietly, avoid work-related activity, and refrain from using electronic devices.
This arm controls for the effect of researcher attention and time spent away from work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Morning Resting Heart Rate Variability (rMSSD) at 4 Weeks
Time Frame: Baseline, Periprocedural and Week 4
|
Baseline, Periprocedural and Week 4
|
|
Change from Baseline in Perceived Stress Level (PSS-10 Score) at 4 Weeks
Time Frame: Baseline and Week 4
|
Baseline and Week 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sleep Quality: Assessed using the Pittsburgh Sleep Quality Index (PSQI) total score
Time Frame: Baseline and Week 4
|
Baseline and Week 4
|
|
General Self-Efficacy: Assessed using the General Self-Efficacy Scale (GSE) score
Time Frame: Baseline and Week 4
|
Baseline and Week 4
|
|
Emotional Well-being: Assessed using the World Health Organization Well-being Index (WHO-5) score
Time Frame: Baseline and Week 4
|
Baseline and Week 4
|
|
Neck Functional Limitation: Assessed using the Neck Disability Index (NDI) score
Time Frame: Baseline and Week 4
|
Baseline and Week 4
|
|
Hand and Shoulder Functionality: Assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire score
Time Frame: Baseline and Week 4
|
Baseline and Week 4
|
|
Acute Pain Intensity Change: Assessed using the Numerical Rating Scale (NRS) score (0-10) in the specific massage area
Time Frame: Periprocedural
|
Periprocedural
|
|
Acute Subjective Well-being Change: Assessed using the Visual Analog Scale (VAS) (0-100 mm) for relaxation, fatigue, and tension
Time Frame: Periprocedural
|
Periprocedural
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age of Participants
Time Frame: Baseline
|
The age of participants calculated from their date of birth.
Years
|
Baseline
|
|
Smoking Status Categories
Time Frame: Baseline
|
The classification of participants' smoking status (e.g., Current Smoker, Former Smoker, Never Smoker).
Count (Number of Participants per Category)
|
Baseline
|
|
Body Mass Index (BMI)
Time Frame: Baseline
|
Body Mass Index, calculated from weight and height.
kg/m2
|
Baseline
|
|
Duration of Sedentary Work Experience
Time Frame: Baseline
|
The total duration of sedentary work experience.
Years
|
Baseline
|
|
Family and Parental Status Categories
Time Frame: Baseline
|
The classification of participants based on their family and parental status (e.g., Married, Unmarried, With Children, Without Children).
Count (Number of Participants per Category)
|
Baseline
|
|
Total Physical Activity Level (IPAQ)
Time Frame: Baseline
|
Total physical activity level score calculated using the International Physical Activity Questionnaire (IPAQ) short form.
Metabolic Equivalent of Task (MET) -minutes/week
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OM_HRV_2025_RCMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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