NCT06972173

Brief Summary

Exam stress in high school students, long hours of studying in the static posture, and lack of physical activity habits can cause physical and psychological discomfort in them. This discomfort can be physically seen as musculoskeletal pain, while as psychologically it can be observed as a decrease in well-being. This situation can cause the acute onset of musculoskeletal pain in students to become chronic with a decrease in well-being. On the contrary, we can observe an increase in musculoskeletal pain due to stress that may occur due to a decrease in well-being. Musculoskeletal pain is a condition that is not fatal but severely impairs health and well-being (1). According to the biopsychosocial model, pain occurs in a complex interaction between biological, psychological and social factors (2). Therefore, pain is both a subjective experience and a physical sensation with large individual differences (3). Relaxation is now a non-pharmacological intervention that has been increasingly accepted in recent years to reduce and cope with pain (4). A person who is relaxed usually has a physical and psychological well-being and feelings of calmness (5). With relaxation exercises, the person starts to reduce anxiety level by coping with stress (6). In addition to relaxation techniques, deep breathing exercise, also known as diaphragmatic breathing, is a technique based on the idea that mind and body integration provides relaxation (7). Breathing exercises are easy to learn and practice and benefit can be obtained from deep breathing exercises performed in a short time (5 minutes of practice may be sufficient) (8). In studies in which both techniques were used separately, it was reported to provide physical and psychological relaxation. The unique aspect of this study is the investigation of the effects of both techniques on pain and well-being in high school students using both techniques simultaneously. For this purpose, we planned to investigate the short-term effects of deep breathing and progressive muscle relaxation exercises on musculoskeletal pain and well-being in high school students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
Last Updated

May 18, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 29, 2025

Last Update Submit

May 14, 2025

Conditions

Keywords

Deep breathing exercisesprogressive muscle relaxation exerciseshigh school studentsmusculoskeletal painwell-being

Outcome Measures

Primary Outcomes (1)

  • musculoskeletal pain

    Cornell Musculoskeletal Disorder Questionnaire (CMDQ): The scale was adapted into Turkish by Erdinç et al. in 2008. This scale assesses the frequency and severity of pain, soreness or discomfort in 11 different body parts (neck, shoulder, back, upper arm, waist, forearm, wrist, hip, upper leg, knee and lower leg) in the last 7 days and whether it interferes with work. Weight scores are calculated according to the answers given for frequency, severity and inability to work.The frequency of pain, aching or discomfort was graded from never (0) to many times every day (4); the severity was graded from mildly severe (1) to very severe (3); and the effect on work performance was graded from never interfered (1) to very much interfered (3). The weighted score for each body part takes a value between 0 and 90.

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

  • WELL-BEING

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

EXERCISE GROUP

EXPERIMENTAL

The exercise program consisting of deep breathing and progressive muscle relaxation exercises was applied to the students in the exercise group. The first exercise session was started the day after the training about the study. During the study period, the program was started at the end of school hours of high school students for a total of 20 sessions (4 weeks, every weekday), each session lasting 30 minutes. The sessions started with deep breathing exercises, continued with progressive muscle relaxation exercises, and ended with deep breathing exercises. For deep breathing exercises, students were asked to place their dominant hand on their abdomen and non-dominant hand on their chest in the semi-fowler position. Afterwards, they were instructed to breath deeply through their nose for 4 seconds and exhale through their mouth for 8 seconds. These exercises were performed as 4 repetitions with 2 minutes rest time between the exercises. When the deep breathing exercise

Other: DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES

CONTROL GROUP

NO INTERVENTION

no treatment was applied to student in the control group.

Interventions

For deep breathing exercises, students were asked to place their dominant hand on their abdomen and non-dominant hand on their chest in the semi-fowler position. Afterwards, they were instructed to breath deeply through their nose for 4 seconds and exhale through their mouth for 8 seconds. These exercises were performed as 4 repetitions with 2 minutes rest time between the exercises. When the deep breathing exercises were finished, the students lay on their backs and rested for 1 minute and then progressive muscle relaxation exercise was started (10,11). For the progressive muscle relaxation exercise, the students were asked to contract and then relax the right foot, left foot, right leg, left leg, hip, abdominal muscles, chest muscles and back muscles, right hand, left hand, right arm, left arm, neck and shoulders, and facial muscles respectively. Respectively, from bottom to top, all the major muscles are contracted while inhaling deeply and slowly, and relaxed and r

EXERCISE GROUP

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırklareli ANATOLIA HIGH SCHOOL

Kırklareli, Central, 39000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exercise and control groups/RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PT, PhD

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 14, 2025

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

May 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
start date: 24,April, 2025 end date: 24, june, 2025

Locations