## Protocol Section
### Identification Module
**NCT ID:** NCT06418191

**Brief Title:** Mobile Apps Enhancing Acupressure Therapy Compliance and Efficacy for Asthenopia

**Official Title:** The Role Of Mobile Applications In Therapy Compliance And Efficacy Of Acupressure In Asthenopia

#### Organization Study ID Info
**ID:** 24-03-0424
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indonesia University

#### Responsible Party

**Investigator Affiliation:** Indonesia University

**Investigator Full Name:** Dion Rukmindar

**Investigator Title:** Medical Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to learn if a mobile application works to improve adherence to acupressure therapy in asthenopia. It will also learn about the efficacy of acupressure as a therapy for asthenopia. The main questions it aims to answer are:

-Does a mobile application have a role to improve therapy compliance and efficacy of self-guided acupressure in asthenopia?

Researchers will compare users of a mobile app to non-users of a mobile app to see if a mobile app works to improve adherence to acupressure therapy in asthenopia

Participants will:

* Do acupressure 2 times every day for 4 weeks
* Filling in the absence link has been after doing acupressure every day
* Fill out the link regarding the condition of asthenopia once per week

**Detailed Description:** This is a clinical trial study to evaluate the role of a mobile application in therapy compliance and acupressure efficacy in asthenopia sufferers. Participants are 60 males/females aged 18-64 years. They will be divided into 2 groups: (1) Acupressure mobile app users and (2) Non-acupressure mobile app users. Acupressure is scheduled 2 times every day for 4 weeks. Therapy compliance will be assessed from the absence link that participants fill out every day, while therapy efficacy will be assessed once per week for 4 weeks.

### Conditions Module

**Conditions:**

- Asthenopia

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mobile application users will be notified twice per day to perform acupressure. Instructions for performing acupressure are in the mobile app

**Intervention Names:**

- Procedure: Acupressure

**Label:** Mobile app users

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Non-users of the mobile application will be given an explanation of how to perform acupressure at the start of the study and will not be reminded to perform acupressure therapy.

**Intervention Names:**

- Procedure: Acupressure

**Label:** Not a mobile app user

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mobile app users

- Not a mobile app user

**Description:** Acupressure is a technique that involves applying pressure to specific points on the body. It is based on the same principles as acupuncture but uses pressure from fingers, palms, elbows, or specialized devices instead of needles.

**Name:** Acupressure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Daily acupressure reports are used to monitor participants' therapeutic compliance in performing acupressure every day

**Measure:** Daily Report of Acupressure

**Time Frame:** 2 times every day for 4 weeks

**Description:** The Modified MMAS-8 questionnaire, also known as the Morisky Medication Adherence Scale-8, is a self-report measure designed to assess acupressure adherence. It consists of eight questions aimed at gauging patients' behaviors and attitudes towards their therapy. The questions focus on factors such as forgetfulness, carelessness, and intentional skipping of medications.

A score of 8 indicates high adherence. Scores between 6 and 7 indicate medium adherence. Scores of 5 or lower indicate low adherence.

**Measure:** Modified Morisky Medication Adherence Scale-8 Questionnaire

**Time Frame:** Monitored every 2 weeks for 4 weeks

#### Secondary Outcomes

**Description:** The Computer Vision Syndrome Questionnaire (CVS-Q) is a tool used to assess symptoms related to prolonged computer use or other digital screens. It typically consists of a series of questions designed to evaluate various discomforts experienced by individuals who spend significant time in front of screens. These questions may inquire about symptoms such as eye strain, headaches, blurred vision, dry eyes, neck or shoulder pain, and general fatigue.

A CVS-Q score ≥ 6 indicates asthenopia

**Measure:** Computer Vision Syndrome Questionnaire (CVS-Q)

**Time Frame:** Monitored once per week for 4 weeks

**Description:** VAS is used to assess complaints of asthenopia intensity on a scale of 1-10

**Measure:** Visual Analog Scale (VAS)

**Time Frame:** Monitored once per week for 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Using a smartphone with the Android platform.
* Work or use digital gadgets for at least 4 hours a day.
* Suffering from asthenopia as indicated by a CVS-Q score ≥ 6.
* Can be contacted with the WhatsApp application.
* Willing to take part in this research until completion and agree to informed consent.

Exclusion Criteria:

* There are tumors, wounds or skin infections in the eye area.

**Healthy Volunteers:** True

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dion.rukmindar@ui.ac.id

**Name:** Dion Rukmindar, MD

**Phone:** +6285217264132

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

**Name:** KEPK FKUI-RSCM

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4555

- Name: Asthenopia

- Relevance: HIGH

- As Found: Asthenopia

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001248

- Term: Asthenopia

### Misc Info Module

- Version Holder: 2024-05-31
