Present research is a randomize clinical trial study with control group, which was carried out to asses the effect of watching nature sights and nature sights with nature sounds on physiologic labour pain and anxiety at Taleghani Hospital in Tabriz. 90 healthy primiparous (30 in each group) being qualified to receive physiologic labour and delivery, will be divided randomly into three groups. All Participants after receiving information about aims and intervention will fill in and sign informed consent. First intervention group will watch the film of nature scenery by flat screen TV. The second group will watch the film of nature scenery with nature sounds. Control group will receive routine physiologic labour care. Interventions in both groups will be carried out during active phase (4-7 Cm dilatation) and will continue till 8 Cm. labour care and control will be done based on National protocol of preparation for labour and delivery. For controlling the effect of environmental intervention such as noise effect, the study will be done in physiologic labour and delivery room, and for having equal one to one care, one researcher will do all care for participants and interventions in group one and group two will be done by same researcher,and researcher assistant will be assess and check pain and anxiety.
Pain will assess visual numerical analogue scale (0-10) every 30 minutes, and anxiety will asses by Spielberger summarized questioner, first upon arrival then every 45 minutes and between showing the film.
General information
Acronym
Doesn't have
IRCT registration information
IRCT registration number:IRCT201405182172N15
Registration date:2014-06-16, 1393/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Tehran University of Medical Sciences
2- Iran University of Medical Sciences
Expected recruitment start date
2014-05-18, 1393/02/28
Expected recruitment end date
2014-08-19, 1393/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of watching nature, and nature with nature sounds on first stage of labar pain and anxiety in primiparous
Public title
The effect of watching nature sights and sights with sounds on pain and anxiety in primiparous in labour
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy Primiparous ; being qualified to doing physiologic delivery; with no infertility history
Exclusion criteria: All mothers are out of natural course of labor due to maternal or fetal condition or mothers aren't qualified to receive physiologic delivery ; Lack of desire to continue participating in study; Mothers who are receive intervention less than 30 minutes
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Sciences
Street address
Resaearch chancellor of Iran University of Medical Science, Close to Milad Tower, Hemat Highway
City
Tehran
Postal code
1996713883
Approval date
2014-05-18, 1393/02/28
Ethics committee reference number
105/813/د/93
2
Ethics committee
Name of ethics committee
Tehran University of Medical Scinces
Street address
School of Nursing and Midwifery , Tehran University of Medica Sciences, Close To Imam KHomeini Hospital, Tohid Square
City
Tehran
Postal code
1419733171
Approval date
2013-10-06, 1392/07/14
Ethics committee reference number
د/1452/130/92
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy
Primary outcomes
1
Description
Pain
Timepoint
After intering to the study, every 30 minutes till 8 cm dilation
Method of measurement
Visual analogue scale of pain
2
Description
Anxiety
Timepoint
Every 50 minutes (45 minutes after intervention and 5 minutes interval till next intervention
Method of measurement
Short Version of Spielberg Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Watching of 45 minutesof nature scenery by flat screen TV.
Category
N/A
2
Description
Watching of 45 minutes of nature scenery along nature sounds by flat screen TV.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital,Tabriz University of Medical Siences
Full name of responsible person
Dr Behzad Sarvaran
Street address
Taleghani hospital, Rahahan Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences (Thesis)
Full name of responsible person
Dr Mohammad Ali Cheraghi
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Dr Mirkhany St. (N.East), Tohid Square
City
Tehran
Grant name
پایان نامه
Grant code / Reference number
23384
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences (Thesis)
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr. Seied Ali Javad Mosavi
Street address
Vice Chancellor for Research, Iran University of Medical Sciences, Close to Milad Tower, Hemat Park Way
City
Tehran
Grant name
طرح تحقیقاتی
Grant code / Reference number
23384
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
Senior Lecturer, Head of Midwifery Countinuing Education OficeM.Sc in Midwifery, M.Sc in Medical Edu
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital, Rashid Yasami St., Valiaasr Ave.
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
+98 21 8820 1978
Email
staavoni14@yahoo.com staavoni@iums.ac.ir
Web page address
www.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
B. Sc in Midwifery, M.Sc in Midwifery Education. M.Sc in Medical Education, PhD student in Medical E
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital, Rashid Yasami St., Valiaasr Ave
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
-
Email
staavoni14@yahoo.com staavoni@iums.ac.ir
Web page address
www.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
B. Sc in Midwifery, M.Sc in Midwifery Education. M.Sc in Medical Education, PhD student in Medical E
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University of Medical, In opposition of Khatamol Anbia Hospital, Rashid Yasami St., Valiaasr Ave.
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 8161
Fax
+98 21 8820 1978
Email
staavoni14@yahoo.com staavoni@iums.ac.ir
Web page address
www.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)