Comparison of the level of comfort and well-being in hemodialysis patients after the use of auditory guided imagery and selected instrumental music
Design
A clinical trial with 2 control groups involving 90 patients, randomized using the Random allocation 2 software
Settings and conduct
The study location is Shahrvand Dialysis Center in Sari city; the study population consists of patients undergoing three hemodialysis sessions per week; and blinding will not be performed in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hemodialysis for at least 6 months; undergoing three hemodialysis sessions per week; hemodynamic stability during dialysis sessions; age over 18 years; full consciousness with the ability to communicate and possess comprehension and understanding of the Persian language. Exclusion criteria: Use of psychotropic medications; use of sedative medications; use of narcotic substances; use of alcohol; pregnancy; use of music in the home or ward
Intervention groups
Intervention group 1: Auditory Guided Imagery, in which a guided imagery audio file will be played to the patient for 20 minutes using headphones; Intervention group 2: Self-Selected Instrumental Music, in which each individual will first select their favorite album and then listen to the tracks on that album for 20 minutes using headphones; Control group: The Control Group will receive no intervention and will undergo the standard dialysis program
Main outcome variables
Level of comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N48
Registration date:2025-12-12, 1404/09/21
Registration timing:prospective
Last update:2025-12-12, 1404/09/21
Update count:0
Registration date
2025-12-12, 1404/09/21
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-19, 1404/10/29
Expected recruitment end date
2026-05-19, 1405/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of audible guided imagery and self -selected instrumental music on comfort and well-being index amounts in hemodialysis patients
Public title
The effect of music and auditory guided imagery on the level of comfort and well being in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing hemodialysis for at least 6 months
Having three hemodialysis sessions per week
Having hemodynamic stability during dialysis sessions
Age over 18 years
Full consciousness and ability to communicate
Having the ability to understand and comprehend the Persian language
Sufficient hearing ability to listen to music and guided visualization instructions, and to use headphones
Exclusion criteria:
Use of psychotropic medications
Use of sedative medications
Use of narcotic substances
Alcohol consumption
Pregnancy
Having any other incurable diseases
Having a history of known psychiatric disorders
Use of music in the home or ward
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
To assign participants into three groups, a stratified block randomization method will be used. Randomization will be conducted in blocks of three participants. The group assignment for each individual will be determined using the Random Allocation Software version 2, employing Stratified Block Randomization based on gender. To construct each 3‑member block, patients will be stratified according to gender. In total, there will be 30 blocks of three participants (15 blocks for males and 15 blocks for females). Based on the codes A, B, and C generated by the software, group allocation will be performed as follows:
code A for the selected instrumental music group, code B for the auditory guided imagery group, and code C for the control group.
Each envelope will be numbered from 1 to 90, and inside each envelope, the codes A, B, and C will be placed following the software-generated random sequence. Each block will be arranged randomly. Sampling will be performed according to the envelope numbers for the first patient who meets the inclusion criteria, and participants will thus be randomly assigned to one of the three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Beginning of Valiasr Highway, Imam Square, Sari
City
Sari
Province
Mazandaran
Postal code
4736131167
Approval date
2025-09-08, 1404/06/17
Ethics committee reference number
IR.MAZUMS.REC.1404.345
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comfort
Timepoint
At the beginning of the study and then at the end of weeks 2 and 4.
Method of measurement
olcaba’s General Comfort Questionnaire (GCQ) for hospitalized patients
Secondary outcomes
1
Description
Well-being
Timepoint
At the beginning of the study and then at the end of weeks 2 and 4.
Method of measurement
WHO well-being index
Intervention groups
1
Description
Intervention Group 1: Auditory Guided Imagery Group: After randomization and determination of the patient’s intervention group type, the inclusion and exclusion criteria are checked, and the necessary explanations regarding the study objectives are provided to the patient. Following the acquisition of written informed consent and completion of the demographic and medical information form, as well as the completion of the Inpatient Comfort Questionnaire and the WHO Well-being Questionnaire by the patient with the researcher’s assistance, the intervention begins. Thirty minutes after connecting the patient to the dialysis machine and stabilizing their condition, an auditory guided imagery audio file will be played for the patient for 20 minutes via headphones connected to the researcher’s mobile phone (the researcher is a master’s student in critical care nursing). This will occur during dialysis sessions, 3 sessions per week , for a total duration of four weeks . The type and brand of the researcher’s mobile phone is a Xiaomi Note 13 Pro, and the type and brand of the headphones are P39 2021. These sessions will involve guided auditory exercises using headphones for positive and soothing mental visualization. The content of the guided imagery audio file includes phrases and sentences that first invite the patient to practice breathing exercises and find a suitable and comfortable position. After the patient is prepared, they are guided to visualize a rainforest and mountain environment, focusing on the details to engage the patient in a calming adventure. The WHO 5-Item Well-being Questionnaire and the Kolcaba's Hospiece Comfort Questionnaire will be completed once before the intervention during the first session of the first week, and then at the end of the second and fourth weeks after the intervention, completed by the patient with the researcher’s assistance. In total, each patient will be assessed 3 times.
Category
Other
2
Description
Second intervention group: Self-Selected Instrumental Music: considering the age range and diverse preferences of patients, 49 musical pieces across five albums of different styles will be used. These include 14 pieces from the traditional Mazandarani instrumental album titled Sor o Sama, 12 pieces of Santour instrumental music, 8 pieces of piano, 8 pieces of violin, and 7 pieces of setar. Each patient has the option to freely choose one of these five albums. The selected album cannot be changed during the same session. The list of tracks in the instrumental album Sor o Sama is as follows: 1‑Te gereh te emsho boro, 2‑Sama hal yek, 3‑Sama hal do, 4‑Rababe jan, 5‑Rana, 6‑Te mahale sang tarashon, 7‑Bolbol nakhoon, 8‑In denge sar oun denge sar, 9‑Zahra mel mahale, 10‑Sevari sama, 11‑Majme sari, 12‑Tayebeh jan, 13‑Binje sama, 14‑Parjai hal.The tracks in the piano album are as follows: 1‑Spring Dance (Shahrdad Rohani), 2‑Jan Maryam (Saeed Rehimi), 3‑Idea 22 (Gibran Alcoser), 4‑Secret and Prayer (Anoushiravan Rohani), 5‑Tears of a Silent Heart (Michael Ortega), 6‑Savior Homayoun (Anna Sophia), 7‑Autumn (from the first Golden Autumn album by Fariborz Lachini), and 8‑Reincarnation (from the second Golden Autumn album by Fariborz Lachini).The violin album includes the following tracks: 1‑Kabuki (Babak Radmanesh), 2‑Jan Maryam (Babak Radmanesh), 3‑Zaman Negaram (Babak Radmanesh), 4‑Laleh (Bijan Mortazavi), 5‑Arshin Malalan (Farid Farjad), 6‑Sarsabz (Bijan Mortazavi), 7‑Orchids and Sickle (Bijan Mortazavi), and 8‑Story of Love (Bijan Mortazavi).The Santour album includes: 1‑Savior (Siamak Aghaei), 2‑Shahr Ashoub (Majid Kiani), 3‑Santour Solo by Kamkar Ensemble, 4‑Rain over Sea (Siavash Kamkar), 5‑Paradise (Faramarz Peyvar from the album Zarb Osoul), 6‑New Spring Blossom (Kian Sedighi), 7‑Colored Pencils (Amin Ahmadi), 8‑Nava (Siavash Kamkar), 9‑Mahour (Faramarz Peyvar), 10‑Four Homayoun Strikes (Parviz Meshkatian), 11‑Bidad (Parviz Meshkatian and Mohammadreza Rostamian), and 12‑Celestial Circle (Soheil Hasanvi).The Setar album includes six pieces by Jalal Zolfonoun — From the Dawn of Time, If I Am Drunk, Delightful Spring, Mazandarani Song, Chahargah Song, and Saqi in Mahour Mode — plus one piece titled Homayoun by Iman Vaziri.Thirty minutes after the patient is connected to the hemodialysis machine and his condition stabilizes, the selected music will be played for the patient via headphones connected to the researcher’s smartphone. The researcher’s device is a Xiaomi Note 13 Pro, and the headphones used are P39 2021. Each session lasts approximately 20 minutes, held three times per week for four weeks. The patient may choose a different album and track in each session but may not switch selections during a single session.The WHO‑5 Well‑Being Questionnaire and the Kolcaba Comfort Questionnaire will be completed by each patient with the assistance of the researcher once before the intervention (in the first session of the first week) and again at the end of weeks two and four following the intervention. In total, each patient will be assessed three times.
Category
Other
3
Description
Control group: The Control Group will receive no intervention and will undergo the standard dialysis program; the World Health Organization’s 5-item Well-Being Index questionnaire and the Kolcaba Comfort Scale for hospitalized patients will be completed by the patient with the researcher’s assistance once before the first session of the first week, and subsequently at the end of the second and fourth weeks; patients in this group, similar to the other two groups, will be assessed and evaluated three times regarding their well-being and comfort variables
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized clinic of Shahrvand Kidney Patients Center
Full name of responsible person
Mansooreh Ezzati
Street address
Mazandaran University of Medical Sciences, Jouybar T-junction
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1985
Email
mansoorehezati1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3397 8055
Email
mansoorehezaty1994@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7551
Email
mbagheri@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Jouybar T-junction, Basij Highway, Imam Square