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IRCT20250803066745N1 IRCT 2025-08-07 Shahre-kord University of Medical Sciences The effect of educational pictograms on sleep quality and activity tolerance in patients with chronic obstructive pulmonary disease. The effect of educational pictogram-based training on sleep quality and activity tolerance in patients with chronic obstructive pulmonary disease. 2025-09-06 anticipated 72 Complete https://irct.ir/trial/85319 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Educational pictogram design by a graphic designer and master's student under the supervision of experienced faculty members, Randomization description: Randomization using sealed envelopes A card-based randomization method was used to assign participants to the intervention and control groups. For this purpose, an equal number of cards were prepared as many as the number of subjects, half of which were labeled “intervention” and the other half “controlThese cards were completely identical, with no apparent differences in size, color, or material, and would be placed in a mixed box or envelope.For each eligible patient who enters the study, a card is randomly drawn from the envelope without prior review, and the patient is placed in the appropriate group based on the card's contents. It should be noted that the researcher was unaware of the contents of the card and the study was double-blind, Blinding description: Participants in this study are blinded to either the intervention or control group. Participants are grouped after selecting cards with similar characteristics, one identifying the control group and the other identifying the intervention group.It should be noted that the control group was also provided with training with images other than the original pictograms, which meant that the person in the control group was unaware of which group they were in. 3 Chronic obstructive pulmonary disease. Intervention 1: Intervention group:In the intervention group, instruction based on educational pictograms, which included information related to disease management, improving sleep quality, and increasing activity tolerance, was provided during an individualized education session for each patient for 20 minutes.It will be conducted by attending each patient's bedside and providing verbal and face-to-face training using educational pictograms and providing information about the pictograms. In severely ill patients, these sessions will be held by the researcher in the patient's hospital room, accompanied by the patient's companion.The content of the sessions is designed so that patients can understand the main concepts related to their disease through simple visual images without the need for complex texts. During this session, in the first five minutes, patients will be provided with information about COPD, its symptoms and complications, and the impact of the disease on sleep quality and daily activities, and familiarization with pictograms.In the second five minutes, proper breathing techniques, use of medications, sprays, devices, symptom control, and sleep pattern modification will be taught with pictograms. In the third five minutes, appropriate physical exercises, methods for increasing activity tolerance and stress management, avoidances, warning signs, and follow-ups will be taughtIn the fourth five minutes, the content of the sessions will be reviewed, patients' questions will be answered, and supplementary points will be provided. Patients will be asked to ask questions or share their experiences. In order to follow up and reinforce learning, patients in the intervention group will receive a set of educational pictogramsWhich includes demonstrating correct breathing techniques, proper sleeping positions, appropriate physical exercises, and care tips. Intervention 2: Control group: In the control group, routine medical care will continue and pictogram-based education will not be provided to these patients, but a series of educational brochures regarding the course of the disease and prevention of symptom exacerbation will be used for blinding.It should be noted that these brochures will not bear any resemblance to the designed pictograms. Yes - There is a plan to make this available What will be shared: The data will be shared after collection and classification, with the names of the participants hidden. When: After completing the thesis writing process, approving the relevant references, extracting the article, and publishing it in reputable journals, access to the data is available. To whom: The collected data is visible to researchers working in medical and paramedical fields. Conditions: The use of data is only available for research and further research in the current and related research field. Where to obtain: To access the data, simply visit Mohammad Rafie's email address at m.rafie78@yahoo.com. How to obtain: Any researcher can obtain data after obtaining the Code of Ethics and the Code of Ethics in Biomedical Research and obtaining permission from Shahrekord University of Medical Sciences. Comments:
public Mohammad Rafi Boldaji
No. 6-Akbar Baldaji Alley- East Dolat Boulevard-Baldaji
Shahrekord Iran (Islamic Republic of) 8876149404 +98 38 3464 3751 m.rafie78@yahoo.com Shahre-kord University of Medical Sciences scientific Mohammad Rafie Boldaji
No. 6-Akbar Baldaji Alley-East Dolat Boulevard-Baldaji
Shahrekord Iran (Islamic Republic of) 8876149404 +98 38 3464 3751 m.rafie78@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) .Definite diagnosis of chronic obstructive pulmonary disease (COPD) by the treating physician. Ability to speak Persian Patients in stages 2 and 3 of the disease according to the GOLD classification Absence of life-threatening diseases Voluntary consent to participate in the study Age between 45 and 70 years Ability to understand and respond to educational pictograms Ability to understand pictograms through the Pictogram Comprehension Test: In this test, patients are presented with several standard pictograms and asked to explain the meaning and concept of each image. The patients' responses are compared with a standard checklist and if the individual correctly identifies at least 70% of the concepts, they are considered to have the ability to understand pictograms Not having mental, motor, visual, or hearing disabilities 45 years 75 years Both History of psychological problems Blindness, deafness, or speechlessness Being in another clinical trial Isolated patients who are in quarantine conditions Patients with motor disabilities Unknown patients who do not have correct identification details Patients with drug addiction J44 Other chronic obstructive pulmonary disease Rehabilitation Behavior Intervention group:In the intervention group, instruction based on educational pictograms, which included information related to disease management, improving sleep quality, and increasing activity tolerance, was provided during an individualized education session for each patient for 20 minutes.It will be conducted by attending each patient's bedside and providing verbal and face-to-face training using educational pictograms and providing information about the pictograms. In severely ill patients, these sessions will be held by the researcher in the patient's hospital room, accompanied by the patient's companion.The content of the sessions is designed so that patients can understand the main concepts related to their disease through simple visual images without the need for complex texts. During this session, in the first five minutes, patients will be provided with information about COPD, its symptoms and complications, and the impact of the disease on sleep quality and daily activities, and familiarization with pictograms.In the second five minutes, proper breathing techniques, use of medications, sprays, devices, symptom control, and sleep pattern modification will be taught with pictograms. In the third five minutes, appropriate physical exercises, methods for increasing activity tolerance and stress management, avoidances, warning signs, and follow-ups will be taughtIn the fourth five minutes, the content of the sessions will be reviewed, patients' questions will be answered, and supplementary points will be provided. Patients will be asked to ask questions or share their experiences. In order to follow up and reinforce learning, patients in the intervention group will receive a set of educational pictogramsWhich includes demonstrating correct breathing techniques, proper sleeping positions, appropriate physical exercises, and care tips. Control group: In the control group, routine medical care will continue and pictogram-based education will not be provided to these patients, but a series of educational brochures regarding the course of the disease and prevention of symptom exacerbation will be used for blinding.It should be noted that these brochures will not bear any resemblance to the designed pictograms. Sleep quality. Timepoint: Before the intervention_Immediately after the intervention_3 months after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Activity tolerance. Timepoint: Before the intervention_Immediately after the intervention_3 months after the intervention. Method of measurement: 6-minute walk test. Decreased time to fall asleep. Timepoint: Before the start of the intervention - Immediately after the end of the intervention - 3 months after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Reduction in nighttime awakenings. Timepoint: Before the start of the intervention - Immediately after the end of the intervention - 3 months after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Feeling refreshed and energetic in the morning. Timepoint: Before the start of the intervention - Immediately after the end of the intervention - 3 months after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Increased distance covered in the 6-minute walk test. Timepoint: Before the start of the intervention - Immediately after the end of the intervention - 3 months after the end of the intervention. Method of measurement: 6-minute walk test. Improve activity time. Timepoint: Before the start of the intervention - Immediately after the end of the intervention - 3 months after the end of the intervention. Method of measurement: 6-minute walk test. Reduce the need to rest during walks. Timepoint: Before the start of the intervention - Immediately after the end of the intervention - 3 months after the end of the intervention. Method of measurement: 6-minute walk test. Shahre-kord University of Medical Sciences Approved 2025-08-02 Ethics Committee of Shahrekord University of Medical Sciences Shahrekord-Headquarters, Kashani Blvd.,-Shahrekord University of Medical Sciences Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)