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

NCT ID: NCT04084275

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

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. A nursing care program which consisted of 8 sessions, the first of which was at the hospital and the others at the homes of puerpera and which were held at different times and lasted 12 weeks in total, based on Levine's Conservation Model was provided to the women in the intervention group. Each session lasted approximately 60-120 minutes, according to the educational and practical contents.The puerpera were given trainings on different subjects based on the module during each session. For these trainings, the investigators prepared, in the light of the literature data, leaflets containing information about breastfeeding, personal hygiene, fatigue, nutrition and pilates exercises

Group Type EXPERIMENTAL

breastfeeding education

Intervention Type BEHAVIORAL

personal hygiene education

Intervention Type BEHAVIORAL

In this training, the puerpera was informed about personal hygiene to prevent infection.

nutrition education

Intervention Type BEHAVIORAL

In this training, the amount of nutrients that breastfeeding women should take daily was explained.

fatigue education

Intervention Type BEHAVIORAL

In this training, suggestions were made to prevent the negative effects of fatigue

sleep education

Intervention Type BEHAVIORAL

In this training, suggestions were offered the puerperants for better sleep. Strategies to improve sleep quality were explained.

pilates exercises education

Intervention Type BEHAVIORAL

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.

control group

The puerpera in the control group received only the standard nursing care given after birth. Standard nursing care contain solely breastfeeding training. The puerpera in the control group were visited before they were discharged from the hospital to obtain their contact information and to administer them the pretest. A home visit at the end of postpartum month 3 was also planned and they were administered the posttest. After collecting the posttest data, the trainings given to the women in the intervention group on nutrition, sleep, fatigue and pilates exercises were also given to the women in the control group in consideration of the ethical dimension of the study; they were actively trained on pilates exercises by the investigator and the relevant leaflets were given to them by the end of their trainings.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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breastfeeding education

Intervention Type BEHAVIORAL

personal hygiene education

In this training, the puerpera was informed about personal hygiene to prevent infection.

Intervention Type BEHAVIORAL

nutrition education

In this training, the amount of nutrients that breastfeeding women should take daily was explained.

Intervention Type BEHAVIORAL

fatigue education

In this training, suggestions were made to prevent the negative effects of fatigue

Intervention Type BEHAVIORAL

sleep education

In this training, suggestions were offered the puerperants for better sleep. Strategies to improve sleep quality were explained.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

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Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Erzincan University

OTHER

Sponsor Role lead

Responsible Party

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Şadiye Özcan

Assistant Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ŞADİYE ÖZCAN, Doctor

Role: PRINCIPAL_INVESTIGATOR

Erzincan university faculty of health sciences

References

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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.

Reference Type BACKGROUND
PMID: 24695771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29609943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29184586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19402799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22023714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27518635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23398359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26125577 (View on PubMed)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

Reference Type BACKGROUND
PMID: 2062970 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10655832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20522068 (View on PubMed)

Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

Reference Type DERIVED
PMID: 34286512 (View on PubMed)

Other Identifiers

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22

Identifier Type: -

Identifier Source: org_study_id

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