NCT06803017

Brief Summary

This study is to examine the effect of music intervention in exercise and sport on problematic smartphone use, psychopathological symptoms, self-esteem, and impulsivity traits in smartphone users among Chinese college students. The aim is to compare the effects of the combination of exercise and sport with fast-tempo music, slow-tempo music, and no music.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

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 7, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

January 17, 2025

Last Update Submit

January 26, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Smartphone Impact Scale (SIS)

    The SIS is a 26-item scale developed in Italian to comprehensively account for smartphones' different cognitive, affective, social, and behavioural impacts in everyday life. The SIS dimensions were measured on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).

    14 weeks

  • Ryerson Social Anxiety Scales (RSAS)

    The RSAS is a new self-report measure designed to assess the extent to which respondents experience fear or anxiety across several social situations (Situations scale), as well as the degree of distress and impairment associated with their social anxiety (Severity scale). Possible scores range from 0 to 28, with higher scores indicating higher social anxiety.

    14 weeks

  • Impulsive Behavior Short Scale-8 (I-8)

    The Impulsive Behavior Short Scale-8 (I-8) measures the psychological construct of impulsivity with four subscales comprising two items each (completion time \< 1 min). I-8 consists of eight items measuring four personality facets that lead to impulsive behaviour: urgency, lack of premeditation, lack of perseverance, and sensation seeking. It was measured on a 4-point Likert scale, ranging from 1 (strongly agree) to 4 (strongly disagree).

    14 weeks

  • Depression Anxiety Stress Scale 8-items (DASS-8)

    The DASS-8 is an 8-item scale that evaluates stress, depression, and anxiety. Items are rated on a 4-point scale ranging from 0 (never or almost never) to 3 (almost always or always).

    14 weeks

  • Multidimensional Self-Esteem Scale-12(MSES-12)

    MSES-12 consists of six subscales comprising 12 items, each rated on a 7-point rating scale ranging from 1 (= not at all) to 7 (= very much) for items measuring the intensity and from 1 (= never) to 7 (= very much) for items measuring frequency.

    14 weeks

  • The SCRAM (Sleep, Circadian Rhythms, and Mood) Questionnaire

    The SCRAM questionnaire contains three 5-item scales measuring sleep quality, diurnal preference, and mood. All items are measured on a 6-point Likert-type scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree).

    14 weeks

Study Arms (3)

combination of exercise and sport with fast-tempo music

EXPERIMENTAL
Behavioral: combination of exercise and sport with fast-tempo music

combination of exercise and sport with slow-temp music

EXPERIMENTAL
Behavioral: combination of exercise and sport with slow-temp music

combination of exercise and sport with no music

EXPERIMENTAL
Behavioral: combination of exercise and sport with no music

Interventions

Fast-tempo music selected by the researcher with exercise training and sports training

combination of exercise and sport with fast-tempo music

Slow-tempo music selected by the researcher with exercise training and sports training

combination of exercise and sport with slow-temp music

Exercise training and sports training without music

combination of exercise and sport with no music

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University students aged between 18 and 25 years old (male or female)
  • No cognitive impairment and able to complete the questionnaire clearly

You may not qualify if:

  • Students with recent injuries such as broken bones, congenital diseases such as heart disease, or other status conditions that prevent them from playing moderate-to-high-intensity sports
  • Excluded students with mental diseases, physical disabilities, or those who were unable or unwilling to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USM

Kota Bharu, Kelantan, 16150, Malaysia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 31, 2025

Study Start

October 7, 2023

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

January 31, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations