The effect of implementation consultative-supportive plan based on the Peplau nursing model on perceived stress, hope and sleep quality of women in waiting time for result of breast biopsy.
Determining the Impact of Counseling-Supportive Program Based on Hildaard Peplove's Model on Perceived Stress, Hope Level and Sleep Quality in Women During the Expectation of the results of the Breast Biopsy.
Design
The study is a randomized, double-group pre-test and post-test clinical trial with concurrent independent or parallel control (Concurrent Control trial). Random assignment will be based on Permuted-Block Randomization. Due to the lack of a similar study to calculate the sample size, a pilot study will be conducted to determine the sample size.
Settings and conduct
The research population is the women referred to the radiology center of Imam Reza hospital in Mashhad, who is diagnosed with a clinical examination of the breast or imaging, needs to be diagnosed with biopsy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; Ability to read and write in Persian; Having phone access to follow the phone; Suspected of breast cancer and having a mass requiring biopsy. Non inclusion criteria: History of cancer and chronic disease; having a disability (mental, hearing, vision and speech) or having a mental illness; major stressful events in the past six months (death of first degree relatives, severe family members, financial bankruptcy, accident, severe family disputes with the spouse)
Intervention groups
The intervention group will receive consultative-supportive plan based on the Peplau nursing mode that includes two face-to-face sessions and two telephone follow-up sessions, and control group will receive the usual care.
Main outcome variables
The stress level; the hope level; the sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180618040128N1
Registration date:2018-10-12, 1397/07/20
Registration timing:registered_while_recruiting
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Somayeh Gohari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 9472
Email address
goharis941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementation consultative-supportive plan based on the Peplau nursing model on perceived stress, hope and sleep quality of women in waiting time for result of breast biopsy.
Public title
The effect of consultative-supportive plan on perceived stress, hope and sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Ability to read and write in Persian
Having access to phone
Suspected of breast cancer and having a mass requiring biopsy
Exclusion criteria:
Cancellation of participation in the study
Taking sedatives, antidepressants or anti-anxiety
History of cancer and chronic diseases
Major stressful events in the past six months (death of first class relatives, severe family members, financial failures, accidents, severe family disputes with the spouse)
Disability (mental, hearing, vision and speech) or mental illness
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be based on Permuted-Block Randomization. For this purpose, the size of each block will be determined initially. Then the list of blocks will be prepared and numbers will be allocated to them. Then, by selecting random numbers, the allocation list will be specified.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Thirteenth floor, block A, Central Headquarters of the Ministry of Health and Medical Education, Sima-e-Iran Street, between South Felamak and Zarafshan streets, Ghods Township
City
Tehran
Province
Razavi Khorasan
Postal code
81455618
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.MUMS.REC.1397.093
Health conditions studied
1
Description of health condition studied
Breast
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Perceived stress
Timepoint
Before the intervention, before receiving the biopsy result and two weeks after receiving the biopsy result
Method of measurement
Cohen Perceived Stress Questionnaire
2
Description
Hope
Timepoint
Before the intervention, before receiving the biopsy result and two weeks after receiving the biopsy result
Method of measurement
Snyder's hope Questionnaire
3
Description
Sleep quality
Timepoint
Before the intervention, before receiving the biopsy result and two weeks after receiving the biopsy result
Method of measurement
Petersburg's Sleep Quality Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group who will apply a counseling-supportive based on the Peplau model, which includes two face-to-face meetings and two follow-up by telephone. Depending on the patient's needs, the nurse-patient communication sessions take 30 to 40 minutes. The first session is formed by the physician after the client's visit and the confirmation of the need for biopsy so that the nurse, by introducing herself and expressing the research goals, will attract the satisfaction of the patients to participate in the study and give a pre-test. The second meeting is face-to-face communication before biopsy and after that, two telephone follow-up will be made to get results.