NCT05711225

Brief Summary

The postpartum period is an important opportunity to improve maternal and fetal health by preventing smoking relapse in women. To achieve this goal, digital platforms, which are the latest technological developments are used. However, studies using digital platforms on smoking cessation and postpartum smoking relapse in pregnant women are limited in this area. The research was carried out to determine the effect of smoking cessation intervention prepared in line with the transtheoretic model on the digital platform, on preventing smoking relapse in the postpartum period. As a result of the research, it is thought that nurses will guide their professional practices with an evidence-based up-to-date approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

December 12, 2022

Last Update Submit

January 31, 2023

Conditions

Keywords

Transtheoretical ModelWeb-based smoking cessation intervention

Outcome Measures

Primary Outcomes (4)

  • Measure 1- The Fagerström Test for Nicotine Dependence

    The Fagerström Test for Nicotine Dependence was developed to determine the level of addiction to cigarettes.The scores that can be obtained from the scale range from 0 to 10. As addiction to cigarette increases, the score obtained from the scale increases. it was determined that the mean score of the scale decreased and the level of addiction decreased in the intervention group.

    15 months

  • Measure 2- Behavior Change Process Scale

    It reveals what processes the individual has experienced in the stages of behavior change.The lowest score that can be obtained from the scale is 22, and the highest is 110. The higher the score obtained from the scale, the higher the chance of success in changing behavior. The higher the score obtained from the scale, the higher the chance of success in changing behavior. It was determined that women in the intervention group had a higher chance of success in changing their smoking behavior.

    15 months

  • Measure 3-Self-Efficacy Scale/Encouraging Factors Scale

    The Self-Efficacy Scale/Encouraging Factors Scale shows the confidence that individuals have in order not to return to the harmful behavior they have changed when faced with difficult situations. The lowest score that can be obtained from the scale is 8 and the highest 40. A high score on the self-efficacy scale reveals the success of not smoking and quitting smoking despite encouraging factors. A high score on the Encouraging Factors Scale indicates that the probability of returning to the harmful behavior is high. The Encouraging Factors Scale is used with an answer format that is the opposite of the Self-Efficacy Scale. Despite the fact that the women in the intervention group faced stimulant situations, not returning to smoking behavior again shows that the power to resist is high.

    15 months

  • Measure 4-Decision Balance Scale

    The decision balance scale reveals the positive and negative perceptions of behavior change. The scale consists of two sub-dimensions that reveal the perception of the positive and negative aspects of smoking. The lowest score that can be obtained for the two sub-dimensions of the scale is 12, and the highest score is 60. A high score on the benefit (positive) sub-dimension indicates his indecision about changing behavior, while a high score on the harm (negative) sub-dimension indicates that has a higher chance of making and continuing a decision on behavior change. It was determined that women in the intervention group were more determined to change their smoking behavior and were more likely to maintain this determination.

    15 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The behavior stage was determined by applying the "Stages of Change Scale" (SCS) form to the pregnant women in the experimental group. The pre-test data from the women in the experimental group were obtained through the website through the Participant Introduction Form,"Behavior Change Process Scale" (BCPS), "Self-Efficacy Scale/Encouraging Factors Scale" (SES/EFS) and "Decision Balance Scale" (DBS) before watching the videos. In addition, FNDT was applied to women who smoked during pregnancy. Post-test data from the women in the experimental group were collected by having them fill out the postpartum part of the Participant Identification Form at the 4th week postpartum after watching the animation videos, and FNDT, SCS, BCPS/EFS and DBS forms for those who still smoke, on the website.

Behavioral: smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse.

Control group

NO INTERVENTION

The behavior stage was determined by applying the "Stages of Change Scale" (SCS) form to the women participating in the control group. The pre-test data of the women participating in the control group were applied via the Participant Identification Form, FNDT, SCS, BCPS/EFS and DBS and the FNDT form to those who continued to smoke during pregnancy. Post-test data from women in the control group were collected with the postpartum part of the Participant Identification Form at 4 weeks postpartum, FNDT, SCS, BCPS/EFS and DBS for smokers.

Interventions

Smoking cessation videos prepared according to the Web-Based Transtheoretic model A module was created on the web, with 5 sections, prepared by the researcher according to the Web-Based Transtheoretic model, for quitting smoking or for pregnant women who quit smoking to maintain this behavior. The modules are prepared in the form of animated videos in which the researcher is educational. Each module is arranged for an average of 5-10 minutes. Theoretical information about the content has been added under each video.

Experimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Don't have a smartphone
  • Having the ability to use the Internet
  • nd gestational week and below
  • Reporting smoking at least two cigarettes per day in the 3 months before conception

You may not qualify if:

  • Not watching videos within the scope of web-based intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semra YILMAZ

Merkez, Adıyaman Province, 02000, Turkey (Türkiye)

Location

Related Publications (19)

  • Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903.

    PMID: 22145828BACKGROUND
  • Lanting CI, van Wouwe JP, van den Burg I, Segaar D, van der Pal-de Bruin KM. [Smoking during pregnancy: trends between 2001 and 2010]. Ned Tijdschr Geneeskd. 2012;156(46):A5092. Dutch.

    PMID: 23151329BACKGROUND
  • Lange S, Probst C, Rehm J, Popova S. National, regional, and global prevalence of smoking during pregnancy in the general population: a systematic review and meta-analysis. Lancet Glob Health. 2018 Jul;6(7):e769-e776. doi: 10.1016/S2214-109X(18)30223-7. Epub 2018 May 31.

    PMID: 29859815BACKGROUND
  • Scheffers-van Schayck T, Tuithof M, Otten R, Engels R, Kleinjan M. Smoking Behavior of Women Before, During, and after Pregnancy: Indicators of Smoking, Quitting, and Relapse. Eur Addict Res. 2019;25(3):132-144. doi: 10.1159/000498988. Epub 2019 Mar 27.

    PMID: 30917383BACKGROUND
  • Caleyachetty R, Thomas GN, Toulis KA, Mohammed N, Gokhale KM, Balachandran K, Nirantharakumar K. Metabolically Healthy Obese and Incident Cardiovascular Disease Events Among 3.5 Million Men and Women. J Am Coll Cardiol. 2017 Sep 19;70(12):1429-1437. doi: 10.1016/j.jacc.2017.07.763.

    PMID: 28911506BACKGROUND
  • Kahyaoğlu S, Özel Ş, Üstün YE, Erdöl C. Gebelik ve Sigara Bırakma. Jinekoloji-Obstetrik ve Neonatoloji Tıp Derg 2018, 15: 1.

    BACKGROUND
  • Tarhan P, Yılmaz T. Gebelikte sigara kullanımı ve etkileyen faktörler. Sağlık Bilimleri ve Meslekleri Derg 2016, 3(3): 140-7.

    BACKGROUND
  • Dilcen HY, Öztürk A, Yıldız MN. Gebelikte Sigara Kullanımının Algılanan Sosyal Destek, Benlik Saygısı ve Psikolojik Sağlamlık ile İlişkisi. Bağımlılık Derg 2021, 22(2): 161-70.

    BACKGROUND
  • Chamberlain C, O'Mara-Eves A, Porter J, Coleman T, Perlen SM, Thomas J, McKenzie JE. Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst Rev. 2017 Feb 14;2(2):CD001055. doi: 10.1002/14651858.CD001055.pub5.

    PMID: 28196405BACKGROUND
  • Harmer C, Memon A. Factors associated with smoking relapse in the postpartum period: an analysis of the child health surveillance system data in Southeast England. Nicotine Tob Res. 2013 May;15(5):904-9. doi: 10.1093/ntr/nts221. Epub 2012 Oct 8.

    PMID: 23045522BACKGROUND
  • Jones M, Lewis S, Parrott S, Wormall S, Coleman T. Re-starting smoking in the postpartum period after receiving a smoking cessation intervention: a systematic review. Addiction. 2016 Jun;111(6):981-90. doi: 10.1111/add.13309. Epub 2016 Mar 16.

    PMID: 26990248BACKGROUND
  • Diamanti A, Papadakis S, Schoretsaniti S, Rovina N, Vivilaki V, Gratziou C, Katsaounou PA. Smoking cessation in pregnancy: An update for maternity care practitioners. Tob Induc Dis. 2019 Aug 2;17:57. doi: 10.18332/tid/109906. eCollection 2019.

    PMID: 31582946BACKGROUND
  • Marufu TC, Ahankari A, Coleman T, Lewis S. Maternal smoking and the risk of still birth: systematic review and meta-analysis. BMC Public Health. 2015 Mar 13;15:239. doi: 10.1186/s12889-015-1552-5.

    PMID: 25885887BACKGROUND
  • Notley C, Gentry S, Livingstone-Banks J, Bauld L, Perera R, Hartmann-Boyce J. Incentives for smoking cessation. Cochrane Database Syst Rev. 2019 Jul 17;7(7):CD004307. doi: 10.1002/14651858.CD004307.pub6.

    PMID: 31313293BACKGROUND
  • Stead LF, Koilpillai P, Fanshawe TR, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Mar 24;3(3):CD008286. doi: 10.1002/14651858.CD008286.pub3.

    PMID: 27009521BACKGROUND
  • Herbec A, Beard E, Brown J, Gardner B, Tombor I, West R. The needs and preferences of pregnant smokers regarding tailored Internet-based smoking cessation interventions: a qualitative interview study. BMC Public Health. 2014 Oct 14;14:1070. doi: 10.1186/1471-2458-14-1070.

    PMID: 25312556BACKGROUND
  • Tombor I, Neale J, Shahab L, Ruiz M, West R. Healthcare providers' views on digital smoking cessation interventions for pregnant women. J Smoking Cessat 2015, 10(2): 116-23.

    BACKGROUND
  • Derksen ME, Kunst AE, Murugesu L, Jaspers MWM, Fransen MP. Smoking cessation among disadvantaged young women during and after pregnancy: Exploring the role of social networks. Midwifery. 2021 Jul;98:102985. doi: 10.1016/j.midw.2021.102985. Epub 2021 Mar 11.

    PMID: 33761432BACKGROUND
  • Dascal M, Rusu A, Onisor A, Blaga O, Miller M, Meghea C. An mHealth intervention to prevent postnatal smoking relapse: The RESPREMO study protocol. Tob Prev Cessat. 2020 Apr 14;6:24. doi: 10.18332/tpc/118724. eCollection 2020.

    PMID: 32548361BACKGROUND

Study Officials

  • SEMRA YILMAZ

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The research was conducted as a pretest-posttest control group experimental model.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 12, 2022

First Posted

February 2, 2023

Study Start

March 24, 2021

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations