The Effect of Care Given Using Levine's Conservation Model on Postpartum Quality of Life in Primiparas

Quality of Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084275
• Other study ID #: 22
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2019
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Postpartum period is a physiologically, emotionally and socially critical period for the woman who gave birth and also for their family. In order for women to go through their postpartum period without any problems, be able to perform self-care and have an unaffected quality of life, they need qualified, comprehensive and integrative nursing care.

Aim and objectives: This study aimed to investigate the effect of care given using Levine's conservation model on postpartum quality of life in primiparae.

Design: A randomized controlled trial. Methods: Levine's conservation model was used as the theoretical framework for this study. A literature review was used to determine the contents of the intervention program. The program consisted of 8 sessions. The puerpera were given trainings on different subjects based on the module during each session. For these trainings, the researcher prepared, in the light of the literature data, leaflets containing information about breastfeeding, personal hygiene, fatigue, nutrition and pilates exercises. The puerpera in the control group received only the standard nursing care given after birth. Standard nursing care contain solely breastfeeding training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

The study included puerpera who

• were in the 18-35 age interval and were at least a primary school graduate,

• had no loss of their senses of vision or hearing,

• were open to communication and cooperation,

• had a nuclear type of family,

• were able to understand and read Turkish,

• were primiparae,

• had a full-term (between weeks 38-42) vaginal delivery,

• had a haemoglobin value of at least 10 mg/dl,

• experienced no risky conditions during gestation (placenta previa, pre-eclampsia, any systemic ailment) or during delivery (ablatio placenta, dystocia, etc.),

• were administered mediolateral episiotomy (because episiotomy impair the integrity of tissue. Healing such episiotomy incisions as soon as possible is quite important to conserve structural integrity).

Exclusion Criteria:

• those who do not meet the eligibility criteria

Related Conditions & MeSH terms

• Breastfeeding
• Levine Conservation Model
• Nursing Caries
• Nursing Model
• Postpartum
• Quality of Life

Intervention

Behavioral:
• breastfeeding education

• personal hygiene education
In this training, the puerpera was informed about personal hygiene to prevent infection.
• nutrition education
In this training, the amount of nutrients that breastfeeding women should take daily was explained.
• fatigue education
In this training, suggestions were made to prevent the negative effects of fatigue
• sleep education
In this training, suggestions were offered the puerperants for better sleep. Strategies to improve sleep quality were explained.
• pilates exercises education
In this study, pilates exercises exclusively for postpartum women were selected from two reference books, Fitness Professional's Handbook and Guide Women's and Fitness Health, which include 13 movements: Bridging, Hundred, Roll Up, One Leg Circle (both ways), Rocker with close legs,Single Straight Leg Stretch, Double Leg Stretch, Spine Stretch Forward, Single Leg Kick, Side Kick up and down, Side Kick circles, Rest position (stretch and relaxation) and Curling. The trainings were provided by the investigator during home visits to the puerpera in the intervention group and the pilates exercises by the investigator who was also a pilates trainer. An appropriate setting was prepared at the homes of puerpera so that they could do the pilates exercises easily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

References & Publications (12)

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Falciglia G, Piazza J, Ritcher E, Reinerman C, Lee SY. Nutrition education for postpartum women: a pilot study. J Prim Care Community Health. 2014 Oct;5(4):275-8. doi: 10.1177/2150131914528515. Epub 2014 Apr 1. — View Citation

Fleming KM, Herring MP. The effects of pilates on mental health outcomes: A meta-analysis of controlled trials. Complement Ther Med. 2018 Apr;37:80-95. doi: 10.1016/j.ctim.2018.02.003. Epub 2018 Feb 13. Review. — View Citation

Gholami Z, Mohammadirizi S, Bahadoran P. Study of the Impact of Educational Behavioral Interventions on Fatigue in Mothers in the Postpartum Period in the Groups of Face-to-Face and Electronic Training. Iran J Nurs Midwifery Res. 2017 Nov-Dec;22(6):465-470. doi: 10.4103/ijnmr.IJNMR_223_15. — View Citation

Hammoudeh W, Mataria A, Wick L, Giacaman R. In search of health: quality of life among postpartum Palestinian women. Expert Rev Pharmacoecon Outcomes Res. 2009 Apr;9(2):123-32. doi: 10.1586/erp.09.8. — View Citation

Huang K, Tao F, Liu L, Wu X. Does delivery mode affect women's postpartum quality of life in rural China? J Clin Nurs. 2012 Jun;21(11-12):1534-43. doi: 10.1111/j.1365-2702.2011.03941.x. Epub 2011 Oct 25. — View Citation

Irwin JL, Beeghly M, Rosenblum KL, Muzik M. Positive predictors of quality of life for postpartum mothers with a history of childhood maltreatment. Arch Womens Ment Health. 2016 Dec;19(6):1041-1050. doi: 10.1007/s00737-016-0653-1. Epub 2016 Aug 12. — View Citation

Ko YL, Yang CL, Fang CL, Lee MY, Lin PC. Community-based postpartum exercise program. J Clin Nurs. 2013 Aug;22(15-16):2122-31. doi: 10.1111/jocn.12117. Epub 2013 Feb 9. — View Citation

Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. — View Citation

Phang KN, Koh SS, Chen HC. Postpartum social support of women in Singapore: A pilot study. Int J Nurs Pract. 2015 May;21 Suppl 2:99-107. doi: 10.1111/ijn.12340. — View Citation

Postpartum care of the mother and newborn: a practical guide. Technical Working Group, World Health Organization. Birth. 1999 Dec;26(4):255-8. — View Citation

Webster J, Nicholas C, Velacott C, Cridland N, Fawcett L. Validation of the WHOQOL-BREF among women following childbirth. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):132-7. doi: 10.1111/j.1479-828X.2009.01131.x. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessed by World Health Organization Quality of Life Assessment Instrument (WHOQOL-Bref)	It is a multi-dimensional measurement tool designed by the World Health Organization to assess quality of life of individuals. The short form of the scale contains four domains and another domain where overall quality of life is evaluated. The domains are physical health, psychological health, social relationships, environment and general health. Each item in the scale is scored as a 5-point rating. Each domain assesses quality of life within itself independent of the others. Higher scores obtained in this scale indicate better quality of life. A study concluded that the short form of the scale was a valid and reliable instrument for the postpartum period. The validity and reliability study of the scale was performed in 1999 to be able to use it in Turkey and the Cronbach's a reliability coefficient of the scale was found to be 0.76 (Eser et al. 1999)	3 months
Primary	Fatigue assessed by Visual Analogue Scale for Fatigue	Developed by Lee et al. in 1991, the scale is used to measure the level of fatigue in healthy and ill individuals. Consisting of 18 items in total, the scale has 13 items to measure the level of fatigue and 5 items to measure the level of energy. There is a 10-cm horizontal line for each item of the scale with positive expressions on one end and negative on the other. Those who complete the scale are asked to mark the point which reflects best the feeling they had when they read the statement in the scale. Afterwards, the points of intersection at the places marked are measured with a ruler one by one for each question and evaluated objectively. Higher scores obtained from the fatigue items and lower scores obtained from the energy items indicate higher severity of fatigue. The validity and reliability study of the scale in Turkey and the Cronbach's a internal consistency coefficient of was found to be 0.90 (Yurtsever and Bedük, 2003).	3 months
Primary	Sleep quality assessed by Pittsburg Sleep Quality Index	Developed by Buysse and associates (1989), the index shows the sleep quality of an individual over the last month as stated by them. There are 19 questions in the index relating to sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction. Each question in the index is scored from 0 to 3. Zero shows having no trouble and 3 having serious trouble sleeping. Higher total scores indicate poorer sleep quality. The validity and reliability study of the index was performed in 1996 to be able to use it in Turkey and the Cronbach's a reliability coefficient of the index was found to be 0.80 (Agargün et al.1996).	3 months